An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects

A Randomized, Open-label, Active-Controlled, Parallel-Group, Exploratory Study on the Effects of Repeated Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02793154

Enrollment

Registered

2016-06-08

Start date

2016-09-26

Completion date

2017-03-16

Last updated

2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

gastric emptying, albiglutide, GMA, exenatide, type 2 diabetes mellitus

Brief summary

The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale \[VAS\]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B. Part B will compare the effects of albiglutide and exenatide on GMA, GE and nausea. Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg) subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a 3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose of exenatide). The total duration of a subject's participation in Part A will be approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to progress to Part B will be made. In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30 milligrams \[mg\] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 4 weeks). The total duration of a subject's participation in the study will be approximately 15 weeks.

Interventions

DRUGExenatide

Supplied as SC injection containing 250 mcg/mL of exenatide, provided in the following dose regimens: Part A: 10 mcg taken twice daily for 5 days; Part B: 5 mcg twice daily taken for 4 weeks followed by uptitration to 10 mcg for 4 weeks In both parts, it will be administered within 60-minute period before morning and evening meals (or before 2 meals with approximate \>=6 hours apart)

DRUGAlbiglutide

Part B: Albiglutide will be supplied as follows:30 mg SC injection pen containing 40.3 mg lyophilized albiglutide and 0.65 mL; 50 mg SC injection pen contains 67 mg lyophilized albiglutide and 0.65 mL water; Starting dose will be 30 mg weekly for 4 weeks and then uptitrated to 50 mg weekly for 4 weeks; Administered as a single SC injection once a week in the morning

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged between 18 and 60 years of age at the time of signing the informed consent. * Type 2 diabetes mellitus diagnosed at least 6 months prior to screening. * Subjects treated with diet and exercise alone or stable dose of single oral antihyperglycemic medication (OAM) of metformin, sulfonylurea (except chlorpropamide), sodium glucose co-transporter 2-inhibitor, or meglitinide for at least 2 months prior to screening * Glycated hemoglobin A1C (HbA1c) \>6.5% and \<=9.0% at screening. If the first HbA1c value does not meet eligibility criterion, the HbA1c may be rechecked once during screening. If the average of these determinations meets the criterion, the subject is eligible. * Fasting plasma glucose (FPG) \<=210 mg/deciliter (dL; central lab) at screening. If the first FPG value does not meet eligibility criterion, the FPG may be rechecked once during screening. * Patient assessment of upper GI symptom severity index at screening: Overall score \<=20 (if score is \>=21 and \<=25, subjects can be re-evaluated 2 weeks later) Total score of items 1-9 is \<=9 Score from any of single item \<=2 * Body mass index (BMI) \>20 kilograms (kg)/meter (m)\^2 and \<35 kg/m\^2 and a stable weight (no more than 5% reported change within 3 months prior to screening). * A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test for females of reproductive potential \[FRP\] only), not breastfeeding, and at least one of the following conditions applies: Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP (eg., combined oral contraceptive pill) from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit. Non-reproductive potential defined as either: * Pre-menopausal with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; or documented bilateral oophorectomy, or; * Postmenopausal defined as 12 months of spontaneous amenorrhea and age appropriate (i.e., \>50 years). In questionable cases, a blood sample with simultaneous follicle stimulating hormone \>40 milli-International units/milliliters (mL) and estradiol \<40 picograms/mL (\<140 picomoles/L) is confirmatory, depending on local laboratory ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment * For the regular use of other medications (does not include protocol excluded medications), subjects must be on a stable dose for at least 4 weeks before screening * Capable of giving signed informed consent; which includes compliance with the requirements and restrictions listed in the consent form and in this protocol

Exclusion criteria

* Type 1 diabetes mellitus * Type 2 diabetes mellitus treated with more than one OAM or with chronic use of insulin within 3 months prior to screening * Hemoglobin \<11 grams (g)/dL (\<110 g/L) for male subjects and \<10 g/dL (\<100 g/L) for female subjects at screening * Fasting triglyceride level \>500 mg/dL at screening * Hemoglobinopathy that may affect proper interpretation of HbA1c * History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed). * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * History of acute or chronic pancreatitis. * History or current severe lactose intolerance * History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening. * Alanine aminotransferase (ALT) \>2.5x upper limit of normal (ULN). * Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * Clinical diagnosis of gastroparesis. * History of significant GI medical conditions such as chronic esophagitis, peptic ulcer diseases, celiac disease, inflammatory bowel disease, unexplained abdominal pain or irritable bowel syndrome and/or history of surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function (e.g., gastric bypass, gastric banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function). * History of hypoglycemia unawareness (i.e., the absence of autonomic warning symptoms before the development of neuroglycopenic symptoms such as blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion). * Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product or may influence data interpretation. * Clinically significant cardiovascular and/or cerebrovascular disease at any time, such as prior myocardial infarction, unstable angina, stroke, transient ischemic attack or documented heart failure, before screening. * Estimated glomerular filtration rate (eGFR) \<=75 mL/min/1.73 m\^2 (calculated using the MDRD formula) at screening. * Lung diseases associated with pulmonary dysfunction (e.g. chronic obstructive pulmonary disease). * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or

Design outcomes

Primary

Measure	Time frame	Description
Part B: Assessment of Nausea by VAS Score	Up to 8 weeks	The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part A: Albumin Level in Urine at Indicated Time Points	Day 5	Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.
Part A: Concentration of Creatinine in Urine at Indicated Time Points	Day 5	Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Day 5	Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.
Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Day 5	Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of 1 for participant 1 actually reflect 0-1.
Part A: Specific Gravity of Urine at Indicated Time Points	Day 5	Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points	Day 5	Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.
Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)	Up to 12 days	An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.
Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD	Up to 12 days	GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.
Part B: Distribution of Average Power by Frequency Region	Up to 8 weeks	EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Up to 8 weeks	EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Up to 8 weeks	EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part A: Distribution of Average Power by Frequency Region	Up to Day 4	The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Up to Day 4	The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Up to Day 4	The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.
Part A: Number of Par. With Shifts in Gastric Rhythm Status	Up to 12 days	EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
Part A: Number Par. by Gastric Rhythm Status	Up to 12 days	EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
Part A: Average Dominant Frequency	Up to Day 4	The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Day 4	The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.
Part A: Time to Half-gastric Emptying	Up to Day 5	Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.
Part A: Rate of [13]C Dose Excreted in Breath	Day 5	The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Up to Day 5	GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.
Part A: The Volume of Water Ingested During EGG	Up to Day 4	The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Day 4	The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Up to 12 days	SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.
Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Up to 12 days	HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Day 5	Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.
Part A: Red Blood Cell (RBC) Count at Indicated Time Points	Day 5	Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.
Part A: Hemoglobin Level at Indicated Time Points	Day 5	Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.
Part A: Hematocrit Level at Indicated Time Points	Day 5	Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Day 5	Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Day 5	Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Day 5	Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points	Day 5	Estimated glomerular filtration rate was calculated using the modification of diet in renal disease (MDRD) formula by multiplying 175 with serum creatinine\^-1.154 multiplied by age\^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented.
Part A: Total Protein, Albumin Levels at Indicated Time Points	Day 5	Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.

Secondary

Measure	Time frame	Description
Part B: Rate of [13]C Dose Excreted in Breath	Up to 8 weeks	The rate of \[13\]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: The Volume of Water Ingested During EGG	Up to 8 weeks	EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Up to 8 weeks	EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With Abnormal Values for Vital Signs	Up to 12 weeks	Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With Abnormal Values for Hematology Parameters	Up to 8 weeks	Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters	Up to 8 weeks	Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With Abnormal Values for Urinalysis	Up to 8 weeks	Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With AEs and SAEs	Up to 12 weeks	An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Assessment of GCSI-DD Score	Up to 8 weeks	GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD	Up to 12 weeks	GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Part B: Time to Half-gastric Emptying	Up to 8 weeks	The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Countries

United States

Participant flow

Recruitment details

This study compared effects of repeated doses of albiglutide and exenatide in type 2 diabetes mellitus. This study was conducted in two parts; first cohort of participants (Par.) were planned to receive exenatide (Part A) and second cohort with albiglutide or exenatide (Part B). There were no pre-specified Primary or Secondary endpoints for Part A.

Pre-assignment details

This study was terminated during exploratory Part A due to the difficulty with enrollment and Part B was cancelled. Hence, Par. received only exenatide subcutaneous (SC) injection in Part A. The data was only collected in Part A and no Par. were enrolled in Part B. All the 4 enrolled Par. completed Part A and no Par. was withdrawn from study.

Participants by arm

Arm	Count
Part A: Exenatide SC Injection Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.	4
Part B: Exenatide SC Injection Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.	0
Part B: Albiglutide SC Injection Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.	0
Total	4

Baseline characteristics

Characteristic	Total	Part A: Exenatide SC Injection
Age, Continuous	56.8 Years STANDARD_DEVIATION 3.3	56.8 Years STANDARD_DEVIATION 3.3
Race/Ethnicity, Customized African American/African Heritage	2 Participants	2 Participants
Race/Ethnicity, Customized White-White/Causasian/European Heritage	2 Participants	2 Participants
Sex: Female, Male Female	1 Participants	1 Participants
Sex: Female, Male Male	3 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 0	0 / 0
other Total, other adverse events	1 / 4	0 / 0	0 / 0
serious Total, serious adverse events	0 / 4	0 / 0	0 / 0

Outcome results

Primary

Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points

Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 1; ALT	21 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 1; AST	20 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 1; GGT	46 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 2; ALT	25 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 2; AST	18 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 2; GGT	76 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 3; ALT	11 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 3; AST	12 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 3; GGT	19 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 4; ALT	17 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 4; AST	20 International unit per liter
Part A: Exenatide SC Injection	Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points	Par. 4; GGT	30 International unit per liter

Primary

Part A: Albumin Level in Urine at Indicated Time Points

Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Albumin Level in Urine at Indicated Time Points	Par. 1	35 Milligrams per liter
Part A: Exenatide SC Injection	Part A: Albumin Level in Urine at Indicated Time Points	Par. 2	35 Milligrams per liter
Part A: Exenatide SC Injection	Part A: Albumin Level in Urine at Indicated Time Points	Par. 3	5 Milligrams per liter
Part A: Exenatide SC Injection	Part A: Albumin Level in Urine at Indicated Time Points	Par. 4	5 Milligrams per liter

Primary

Part A: Assessment of Heart Rate (HR) as a Measure of Safety

HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.

Time frame: Up to 12 days

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 1; Day -1	69 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 1; Day 1	65 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 1; Day 4	66 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 1; Day 5	84 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 1; Follow-up	68 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 2; Day -1	57 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 2; Day 1	64 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 2; Day 4	62 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 2; Day 5	82 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 2; Follow-up	58 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 3; Day -1	72 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 3; Day 1	74 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 3; Day 4	78 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 3; Day 5	82 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 3; Follow-up	78 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 4; Day -1	78 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 4; Day 1	89 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 4; Day 4	77 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 4; Day 5	82 Beats per minute
Part A: Exenatide SC Injection	Part A: Assessment of Heart Rate (HR) as a Measure of Safety	Par. 4; Follow-up	72 Beats per minute

Primary

Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score

The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.

Time frame: Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 2; Day 4; Pre-WL	3 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 1; Day 4; Pre-WL	4 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 1; Day 4; 10 minutes Post-WL	2 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 1; Day 4; 20 minutes Post-WL	4 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 1; Day 4; 30 minutes Post-WL	3 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 2; Day 4; 10 minutes Post-WL	4 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 2; Day 4; 20 minutes Post-WL	4 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 2; Day 4; 30 minutes Post-WL	24 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 3; Day 4; Pre-WL	1 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 3; Day 4; 10 minutes Post-WL	0 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 3; Day 4; 20 minutes Post-WL	0 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 3; Day 4; 30 minutes Post-WL	0 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 4; Day 4; Pre-WL	4 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 4; Day 4; 10 minutes Post-WL	5 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 4; Day 4; 20 minutes Post-WL	3 Scores on a scale
Part A: Exenatide SC Injection	Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score	Par. 4; Day 4; 30 minutes Post-WL	4 Scores on a scale

Primary

Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score

The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.

Time frame: Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; Pre-WL; Stomach fullness	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 10 minutes Post-WL;Stomach fullness	43 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Stomach fullness;Day 4; 20 minutes Post-WL	50 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 30 minutes Post-WL;Stomach fullness	9 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; Pre-WL;Stomach fullness	11 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 10 minutes Post-WL;Stomach fullness	94 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 20 minutes Post-WL;Stomach fullness	92 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 30 minutes Post-WL;Stomach fullness	85 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; Pre-WL; Stomach fullness	10 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 10 minutes Post-WL;Stomach fullness	89 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 20 minutes Post-WL;Stomach fullness	82 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 30 minutes Post-WL;Stomach fullness	75 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; Pre-WL;Stomach fullness	28 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 10 minutes Post-WL;Stomach fullness	34 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 20 minutes Post-WL;Stomach fullness	38 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 30 minutes Post-WL;Stomach fullness	35 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; Pre-WL; Bloating	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 10 minutes Post-WL;Bloating	27 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 20 minutes Post-WL;Bloating	46 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 30 minutes Post-WL; Bloating	45 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; Pre-WL;Bloating	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 10 minutes Post-WL;Bloating	5 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 20 minutes Post-WL;Bloating	6 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 30 minutes Post-WL;Bloating	26 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Bloating; Day 4; Pre-WL;Bloating	1 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 10 minutes Post-WL;Bloating	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 20 minutes Post-WL;Bloating	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 30 minutes Post-WL;Bloating	1 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; Pre-WL; Bloating	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 10 minutes Post-WL;Bloating	22 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 20 minutes Post-WL; Bloating	42 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Bloating; Day 4; 30 minutes Post-WL	35 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; Pre-WL; Abdominal pain	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 10 minutes Post-WL; Abdominal pain	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 20 minutes Post-WL; Abdominal pain	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 30 minutes Post-WL;Abdominal pain	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; Pre-WL; Abdominal pain	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 10 minutes Post-WL; Abdominal pain	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 20 minutes Post-WL; Abdominal pain	7 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 30 minutes Post-WL;Abdominal pain	6 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; Pre-WL; Abdominal pain	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3;Day 4; 10 minutes Post-WL; Abdominal pain	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 20 minutes Post-WL; Abdominal pain	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 30 minutes Post-WL; Abdominal pain	0 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; Pre-WL; Abdominal pain	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 10 minutes Post-WL;Abdominal pain	4 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 20 minutes Post-WL; Abdominal pain	5 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 30 minutes Post-WL; Abdominal pain	5 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; Pre-WL; Hunger	88 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 10 minutes Post-WL; Hunger	79 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1; Day 4; 20 minutes Post-WL;Hunger	85 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 1;Day 4; 30 minutes Post-WL;Hunger	84 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; Pre-WL;Hunger	32 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 10 minutes Post-WL; Hunger	16 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 20 minutes Post-WL; Hunger	19 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 2; Day 4; 30 minutes Post-WL; Hunger	27 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; Pre-WL; Hunger	21 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 10 minutes Post-WL; Hunger	3 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 20 minutes Post-WL; Hunger	6 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 3; Day 4; 30 minutes Post-WL;Hunger	17 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; Pre-WL;Hunger	19 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 10 minutes Post-WL; Hunger	16 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 20 minutes Post-WL; Hunger	29 Scores on VAS scale
Part A: Exenatide SC Injection	Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score	Par. 4; Day 4; 30 minutes Post-WL;Hunger	37 Scores on VAS scale

Primary

Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety

SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.

Time frame: Up to 12 days

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day -1; SBP	126 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 1; SBP	121 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 4; SBP	124 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 5; SBP	112 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Follow-up; SBP	125 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day -1; DBP	71 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 1; DBP	61 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 4; DBP	69 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Day 5; DBP	67 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 1; Follow-up; DBP	72 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day -1; SBP	105 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 1; SBP	109 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 4; SBP	119 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 5; SBP	121 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Follow-up; SBP	124 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day -1; DBP	61 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 1; DBP	68 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 4; DBP	71 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Day 5; DBP	68 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 2; Follow-up; DBP	75 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day -1; SBP	131 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 1; SBP	131 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 4; SBP	132 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 5; SBP	112 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Follow-up; SBP	126 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day -1; DBP	86 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 1; DBP	82 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 4; DBP	87 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Day 5; DBP	76 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 3; Follow-up; DBP	87 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day -1; SBP	138 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 1; SBP	139 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 4; SBP	127 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 5; SBP	123 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Follow-up; SBP	160 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day -1; DBP	83 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 1; DBP	90 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 4; DBP	83 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Day 5; DBP	81 Millimeter of mercury
Part A: Exenatide SC Injection	Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety	Par. 4; Follow-up; DBP	86 Millimeter of mercury

Primary

Part A: Average Dominant Frequency

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.

Time frame: Up to Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 1; Pre-WL; Bradygastria	1.5 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	0.75 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	1.25 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	2.19 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 4; Pre-WL; Bradygastria	1.05 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	0.96 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	1.25 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	2.38 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 1; Pre-WL; Bradygastria	1 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	1 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	1.5 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	1.75 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 4; Pre-WL; Bradygastria	0.75 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	1.38 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	1 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	2.42 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 1; Pre-WL; Bradygastria	0.96 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	1.83 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 1; 20 minutes Post-WL; Normal	3 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	4.13 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 4; Pre-WL; Bradygastria	1.2 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	1.5 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	0.94 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	1.5 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 1; Pre-WL; Bradygastria	0.86 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	1.88 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	1.7 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	1.19 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 4; Pre-WL; Bradygastria	1.2 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	0.94 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	1.29 Cycles per minute
Part A: Exenatide SC Injection	Part A: Average Dominant Frequency	Par. 4; Day 4; 30 minutes Post-WL; Normal	2.9 Cycles per minute

Primary

Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points

Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Basophils	0.02 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Eosinophils	0.11 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Lymphocytes	1.57 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Monocytes	0.35 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Platelet count	268 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; Total Neutrophils	6.33 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.1; WBC	8.4 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Basophils	0.02 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Eosinophils	0.04 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Lymphocytes	1.39 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Monocytes	0.25 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Platelet count	217 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; Total Neutrophils	2.54 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.2; WBC	4.2 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Basophils	0.03 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Eosinophils	0.21 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Lymphocytes	1.77 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Monocytes	0.58 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Platelet count	202 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; Total Neutrophils	5.09 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.3; WBC	7.7 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Basophils	0.04 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Eosinophils	0.23 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Lymphocytes	3.06 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Monocytes	0.89 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Platelet count	230 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; Total Neutrophils	1.2 Giga unit per liter
Part A: Exenatide SC Injection	Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points	Par.4; WBC	5.4 Giga unit per liter

Primary

Part A: Concentration of Creatinine in Urine at Indicated Time Points

Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Concentration of Creatinine in Urine at Indicated Time Points	Par. 1	12450 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Concentration of Creatinine in Urine at Indicated Time Points	Par. 2	16240 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Concentration of Creatinine in Urine at Indicated Time Points	Par. 3	13300 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Concentration of Creatinine in Urine at Indicated Time Points	Par. 4	22020 Micromoles per liter

Primary

Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points

Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 1; Creatinine	67.2 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 1; Direct Bilirubin	2 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 1; Total Bilirubin	10 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 1; Indirect Bilirubin	8 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 2; Creatinine	105.2 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 2; Direct Bilirubin	2 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 2; Total Bilirubin	6 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 2; Indirect Bilirubin	4 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 3; Creatinine	76.9 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 3; Direct Bilirubin	4 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 3; Total Bilirubin	16 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 3; Indirect Bilirubin	12 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 4; Creatinine	83.1 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 4; Direct Bilirubin	2 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 4; Total Bilirubin	6 Micromoles per liter
Part A: Exenatide SC Injection	Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points	Par. 4; Indirect Bilirubin	4 Micromoles per liter

Primary

Part A: Distribution of Average Power by Frequency Region

The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.

Time frame: Up to Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; Pre-WL; Bradygastria	56.15 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; Pre-WL; Normal	23.49 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; Pre-WL; Tachygastria	17 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; Pre-WL; Duodenal	3.35 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	93.97 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Normal	2.9 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	2.4 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0.73 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	57.13 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Normal	23.29 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	13.17 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Duodenal	6.41 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	43.44 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Normal	36.16 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	17.78 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Duodenal	2.62 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; Pre-WL; Bradygastria	71.94 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; Pre-WL; Normal	13 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; Pre-WL; Tachygastria	9.51 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; Pre-WL; Duodenal	5.55 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	43.99 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Normal	12.94 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	28.33 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Duodenal	14.74 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	73.87 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Normal	10.97 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	8.77 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Duodenal	6.39 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	48.87 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Normal	16.66 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	23.16 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Duodenal	11.31 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; Pre-WL; Bradygastria	67.44 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; Pre-WL; Normal	10.67 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; Pre-WL; Tachygastria	17.2 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; Pre-WL; Duodenal	4.68 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	94.05 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Normal	2.46 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	2.83 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0.67 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	85.64 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Normal	11.72 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	2.43 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0.22 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	77.34 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Normal	15.57 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	6.23 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0.86 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; Pre-WL; Bradygastria	43.32 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; Pre-WL; Normal	23.82 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; Pre-WL; Tachygastria	18.71 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; Pre-WL; Duodenal	14.14 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	84.23 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Normal	7.93 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	6.81 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Duodenal	1.02 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	66.32 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Normal	19.43 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	11.7 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Duodenal	2.55 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	73.05 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Normal	19.64 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	6.47 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0.84 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; Pre-WL; Bradygastria	59.66 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; Pre-WL; Normal	9.05 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; Pre-WL; Tachygastria	22.39 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; Pre-WL; Duodenal	8.91 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	32.73 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Normal	11.03 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	13.26 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	48.77 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Duodenal	7.47 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	29.94 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Normal	22.84 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	39.72 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Duodenal	7.5 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	16.32 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Normal	22.48 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	54.77 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Duodenal	6.43 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; Pre-WL; Bradygastria	52.85 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; Pre-WL; Normal	16.64 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; Pre-WL; Tachygastria	13.21 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; Pre-WL; Duodenal	17.29 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	64.27 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Normal	10.37 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Duodenal	12.1 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	71.66 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Normal	11.11 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	9.52 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Duodenal	7.72 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	53.97 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Normal	8.61 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	16.12 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Duodenal	21.3 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; Pre-WL; Bradygastria	82.47 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; Pre-WL; Normal	6.66 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; Pre-WL; Tachygastria	7.86 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; Pre-WL; Duodenal	3.01 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	81.89 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Normal	5.6 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	11.63 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0.88 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	62.96 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Normal	12.84 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	17.04 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Duodenal	7.17 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	73.64 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Normal	12.7 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	11.1 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Duodenal	2.56 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; Pre-WL; Bradygastria	54.98 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; Pre-WL; Normal	17.6 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; Pre-WL; Tachygastria	22.97 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; Pre-WL; Duodenal	4.45 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	83.7 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Normal	4.2 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	10.69 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Duodenal	1.4 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	82.96 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Normal	5.92 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	10.1 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Duodenal	1.02 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	39.01 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Normal	42.61 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	16.77 Percentage of power
Part A: Exenatide SC Injection	Part A: Distribution of Average Power by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Duodenal	1.62 Percentage of power

Primary

Part A: Estimated Glomerular Filtration Rate at Indicated Time Points

Estimated glomerular filtration rate was calculated using the modification of diet in renal disease (MDRD) formula by multiplying 175 with serum creatinine\^-1.154 multiplied by age\^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Estimated Glomerular Filtration Rate at Indicated Time Points	Part. 1	1.3026 Milliliter per second per 1.73 meter ^2
Part A: Exenatide SC Injection	Part A: Estimated Glomerular Filtration Rate at Indicated Time Points	Part. 2	1.2859 Milliliter per second per 1.73 meter ^2
Part A: Exenatide SC Injection	Part A: Estimated Glomerular Filtration Rate at Indicated Time Points	Part. 3	1.5197 Milliliter per second per 1.73 meter ^2
Part A: Exenatide SC Injection	Part A: Estimated Glomerular Filtration Rate at Indicated Time Points	Part. 4	1.6533 Milliliter per second per 1.73 meter ^2

Primary

Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.

Time frame: Up to Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day-1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 4; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 5; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day -1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 4; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 1; Day 5; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Nausea	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Nausea	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Excessively full after meals	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Excessively full after meals	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Excessively full after meals	5 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Excessively full after meals	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Bloating	5 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Unable to finish normal-sized meal	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Unable to finish normal-sized meal	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Unable to finish normal-sized meal	5 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Unable to finish normal-sized meal	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Retching	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Retching	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Stomach fullness	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Stomach fullness	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Stomach fullness	5 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Stomach fullness	5 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Loss of appetite	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Loss of appetite	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Loss of appetite	2 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Upper abdominal pain	3 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Upper abdominal discomfort	3 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day -1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 4; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par 1; Day 5; Overall severity of gastroparesis	4 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2 Day 1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Stomach fullness	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day -1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 4; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 2; Day 5; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day -1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 4; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 3; Day 5; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Epi of vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Epi of retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Nausea	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Excessively full after meals	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Excessively full after meals	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Excessively full after meals	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Bloating	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Bloating	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par.4; Day -1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par.4; Day 1; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par.4; Day 4; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par.4; Day 5; Unable to finish normal-sized meal	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Retching	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Vomiting	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Stomach or belly visibly larger	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Stomach fullness	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Stomach fullness	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Stomach fullness	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Loss of appetite	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Upper abdominal pain	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Upper abdominal discomfort	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day -1; Overall severity of gastroparesis	0 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 1; Overall severity of gastroparesis	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 4; Overall severity of gastroparesis	1 Scores on GCSI-DD scale
Part A: Exenatide SC Injection	Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score	Par. 4; Day 5; Overall severity of gastroparesis	0 Scores on GCSI-DD scale

Primary

Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels

Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Glucose	9.2 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Calcium	2.44 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Magnesium	0.86 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Potassium	5.6 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Sodium	139 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Phosphorus inorganic	1.5 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Chloride	105 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 1; Urea/BUN	7.5 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Glucose	7.5 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Calcium	2.44 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Magnesium	0.9 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Potassium	5.1 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Sodium	139 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Phosphorus inorganic	1.25 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Chloride	105 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 2; Urea/BUN	6.5 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Glucose	9.1 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Calcium	2.38 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Magnesium	0.8 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Potassium	4.2 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Sodium	140 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Phosphorus inorganic	1.2 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Chloride	103 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 3; Urea/BUN	7 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Glucose	7.9 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Calcium	2.4 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Magnesium	0.8 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Potassium	4.3 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Sodium	138 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Phosphorus inorganic	1.15 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Chloride	101 Millimoles per liter
Part A: Exenatide SC Injection	Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels	Par. 4; Urea/BUN	4.5 Millimoles per liter

Primary

Part A: Hematocrit Level at Indicated Time Points

Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Hematocrit Level at Indicated Time Points	Par. 1	0.399 Proportion of RBC in blood
Part A: Exenatide SC Injection	Part A: Hematocrit Level at Indicated Time Points	Par. 2	0.426 Proportion of RBC in blood
Part A: Exenatide SC Injection	Part A: Hematocrit Level at Indicated Time Points	Par. 3	0.466 Proportion of RBC in blood
Part A: Exenatide SC Injection	Part A: Hematocrit Level at Indicated Time Points	Par. 4	0.462 Proportion of RBC in blood

Primary

Part A: Hemoglobin Level at Indicated Time Points

Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Hemoglobin Level at Indicated Time Points	Par. 1	125 Grams per liter
Part A: Exenatide SC Injection	Part A: Hemoglobin Level at Indicated Time Points	Par. 2	133 Grams per liter
Part A: Exenatide SC Injection	Part A: Hemoglobin Level at Indicated Time Points	Par. 3	149 Grams per liter
Part A: Exenatide SC Injection	Part A: Hemoglobin Level at Indicated Time Points	Par. 4	156 Grams per liter

Primary

Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)

An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.

Time frame: Up to 12 days

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)	Any AE	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)	Any SAE	0 Participants

Primary

Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.

Time frame: Up to 12 days

Population: All Subjects Population.

Arm	Measure	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD	0 Participants

Primary

Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points

Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 1; Ketones; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 1; Occult blood; Trace	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 1; Glucose	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 1; Nitrates	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 1; Leukocyte esterase	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 2; Ketones; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 2; Occult blood; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 2; Glucose	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 2; Nitrates	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 2; Leukocyte esterase	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 3; Ketones; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 3; Occult blood; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 3; Glucose	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 3; Nitrates	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 3; Leukocyte esterase	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 4; Ketones; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 4; Occult blood; Negative	1 Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par. 4; Glucose	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 4; Nitrates	NA Participants
Part A: Exenatide SC Injection	Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points	Par 4; Leukocyte esterase	NA Participants

Primary

Part A: Number of Par. With Shifts in Gastric Rhythm Status

EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

Time frame: Up to 12 days

Population: Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

Primary

Part A: Number Par. by Gastric Rhythm Status

Time frame: Up to 12 days

Population: Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.

Primary

Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.

Time frame: Up to Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; Pre-WL; Bradygastria	80 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; Pre-WL; Normal	20 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 30 minutes Post-WL; Normal	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 1; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 30 minutes Post-WL; Normal	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 1; Day 4; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 30 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 30 minutes Post-WL; Normal	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 20 minutes Post-WL; Normal	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 30 minutes Post-WL; Normal	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	50 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 1; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 30 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 3; Day 4; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 30 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 1; 30 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; Pre-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; Pre-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; Pre-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; Pre-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 10 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 10 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	100 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 20 minutes Post-WL; Normal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 20 minutes Post-WL; Duodenal	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	0 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 30 minutes Post-WL; Normal	80 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	20 Percentage of time
Part A: Exenatide SC Injection	Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal	Par. 4; Day 4; 30 minutes Post-WL; Duodenal	0 Percentage of time

Primary

Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points

Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points	Par. 1	5 Points on a scale
Part A: Exenatide SC Injection	Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points	Par. 2	5.5 Points on a scale
Part A: Exenatide SC Injection	Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points	Par. 3	6 Points on a scale
Part A: Exenatide SC Injection	Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points	Par. 4	5 Points on a scale

Primary

Part A: Presence RBC and WBC in Urine Assessed by Microscopy

Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of 1 for participant 1 actually reflect 0-1.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Par.1; RBC	1 High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Par. 1; WBC	1 High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Par. 2; RBC	NA High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Par. 2; WBC	NA High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Par. 3; RBC	NA High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Part. 3; WBC	NA High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Part 4; RBC	NA High Power field
Part A: Exenatide SC Injection	Part A: Presence RBC and WBC in Urine Assessed by Microscopy	Part. 4; WBC	NA High Power field

Primary

Part A: Rate of [13]C Dose Excreted in Breath

The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.

Time frame: Day 5

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; Pre-Meal	0 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 45 Minutes Post-Meal	1.8 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 90 Minutes Post-Meal	3.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 120 Minutes Post-Meal	3.1 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 150 Minutes Post-Meal	3.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 180 Minutes Post-Meal	7.4 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 1; Day 5; 240 Minutes Post-Meal	21.1 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; Pre-Meal	0 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 45 Minutes Post-Meal	22.2 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 90 Minutes Post-Meal	42.5 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 120 Minutes Post-Meal	66.5 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 150 Minutes Post-Meal	82.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 180 Minutes Post-Meal	84.7 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 2; Day 5; 240 Minutes Post-Meal	75.8 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; Pre-Meal	0 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 45 Minutes Post-Meal	1 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 90 Minutes Post-Meal	2.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 120 Minutes Post-Meal	6.5 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 150 Minutes Post-Meal	16.4 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 180 Minutes Post-Meal	28.2 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 3; Day 5; 240 Minutes Post-Meal	56.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; Pre-Meal	0 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 45 Minutes Post-Meal	11.3 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 90 Minutes Post-Meal	27.8 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 120 Minutes Post-Meal	39.6 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 150 Minutes Post-Meal	51.1 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 180 Minutes Post-Meal	59.8 kPCD per minute
Part A: Exenatide SC Injection	Part A: Rate of [13]C Dose Excreted in Breath	Par. 4; Day 5; 240 Minutes Post-Meal	61.6 kPCD per minute

Primary

Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.

Time frame: Up to Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 10 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 20 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 1; 30 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 10 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 20 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Bradygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 1; Day 4; 30 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Bradygastria	0.01 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 10 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Bradygastria	0.04 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Normal	0.04 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 20 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Bradygastria	0.01 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Normal	0.02 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 1; 30 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Bradygastria	0.03 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Normal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Tachygastria	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 10 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Bradygastria	0.03 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Normal	0.02 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Tachygastria	0.01 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 20 minutes Post-WL; Duodenal	0 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Bradygastria	0.22 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Normal	0.11 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Tachygastria	0.05 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 2; Day 4; 30 minutes Post-WL; Duodenal	0.01 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Bradygastria	0.13 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Normal	0.29 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Tachygastria	0.52 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 10 minutes Post-WL; Duodenal	0.2 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Bradygastria	0.2 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Normal	0.99 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Tachygastria	0.7 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 20 minutes Post-WL; Duodenal	0.33 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Bradygastria	0.15 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Normal	1.38 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Tachygastria	1.36 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 1; 30 minutes Post-WL; Duodenal	0.4 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Bradygastria	0.16 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Normal	0.08 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Tachygastria	0.13 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 10 minutes Post-WL; Duodenal	0.09 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Bradygastria	0.2 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Normal	0.1 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Tachygastria	0.11 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 20 minutes Post-WL; Duodenal	0.07 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Bradygastria	0.16 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Normal	0.08 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Tachygastria	0.19 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 3; Day 4; 30 minutes Post-WL; Duodenal	0.19 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Bradygastria	2.6 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Normal	2.21 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Tachygastria	3.88 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 10 minutes Post-WL; Duodenal	0.76 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Bradygastria	0.89 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Normal	2.24 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Tachygastria	2.52 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 20 minutes Post-WL; Duodenal	2.76 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Bradygastria	1.54 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Normal	3.29 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Tachygastria	2.44 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 1; 30 minutes Post-WL; Duodenal	1.47 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Bradygastria	4.7 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Normal	0.74 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Tachygastria	1.44 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 10 minutes Post-WL; Duodenal	0.97 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Bradygastria	10.24 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Normal	2.28 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Tachygastria	2.98 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 20 minutes Post-WL; Duodenal	1.55 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Bradygastria	3.4 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Normal	11.6 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Tachygastria	3.5 Ratio
Part A: Exenatide SC Injection	Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region	Par. 4; Day 4; 30 minutes Post-WL; Duodenal	1.74 Ratio

Primary

Part A: Red Blood Cell (RBC) Count at Indicated Time Points

Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Red Blood Cell (RBC) Count at Indicated Time Points	Par. 1	4.7 Tetra unit per liter
Part A: Exenatide SC Injection	Part A: Red Blood Cell (RBC) Count at Indicated Time Points	Par. 2	4.8 Tetra unit per liter
Part A: Exenatide SC Injection	Part A: Red Blood Cell (RBC) Count at Indicated Time Points	Par. 3	5 Tetra unit per liter
Part A: Exenatide SC Injection	Part A: Red Blood Cell (RBC) Count at Indicated Time Points	Par. 4	4.9 Tetra unit per liter

Primary

Part A: Specific Gravity of Urine at Indicated Time Points

Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Specific Gravity of Urine at Indicated Time Points	Par. 1	1.021 Kilograms per meter^3
Part A: Exenatide SC Injection	Part A: Specific Gravity of Urine at Indicated Time Points	Par. 2	1.019 Kilograms per meter^3
Part A: Exenatide SC Injection	Part A: Specific Gravity of Urine at Indicated Time Points	Par. 3	1.023 Kilograms per meter^3
Part A: Exenatide SC Injection	Part A: Specific Gravity of Urine at Indicated Time Points	Par. 4	1.027 Kilograms per meter^3

Primary

Part A: The Volume of Water Ingested During EGG

The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.

Time frame: Up to Day 4

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 1; Day 1	430 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 1; Day 4	360 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 2; Day 1	2160 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 2; Day 4	1980 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 3; Day 1	900 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 3; Day 4	1080 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 4; Day 1	1000 Milliliter
Part A: Exenatide SC Injection	Part A: The Volume of Water Ingested During EGG	Par. 4; Day 4	1000 Milliliter

Primary

Part A: Time to Half-gastric Emptying

Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.

Time frame: Up to Day 5

Population: Pharmacodynamic Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 1; Day -1	87.2 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 1; Day 5	226.5 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 2; Day -1	73.0 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 2; Day 5	75.5 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 3; Day -1	57.6 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 3; Day 5	174.0 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 4; Day -1	52.9 Minutes
Part A: Exenatide SC Injection	Part A: Time to Half-gastric Emptying	Par. 4; Day 5	103.8 Minutes

Primary

Part A: Total Protein, Albumin Levels at Indicated Time Points

Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.

Time frame: Day 5

Population: All Subjects Population

Arm	Measure	Group	Value (NUMBER)
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 1; Total Protein	77 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 1; Albumin levels	43 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 2; Total Protein	75 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 2; Albumin levels	46 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 3; Total Protein	71 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 3; Albumin levels	44 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 4; Total Protein	74 Grams per liter
Part A: Exenatide SC Injection	Part A: Total Protein, Albumin Levels at Indicated Time Points	Par. 4; Albumin levels	46 Grams per liter

Primary

Part B: Assessment of Nausea by VAS Score

The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Primary

Part B: Distribution of Average Power by Frequency Region

EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Primary

Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Primary

Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Assessment of GCSI-DD Score

GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score

EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters

Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With Abnormal Values for Hematology Parameters

Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With Abnormal Values for Urinalysis

Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With Abnormal Values for Vital Signs

Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 12 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With AEs and SAEs

An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 12 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

Time frame: Up to 12 weeks

Population: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Rate of [13]C Dose Excreted in Breath

The rate of \[13\]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: The Volume of Water Ingested During EGG

EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Secondary

Part B: Time to Half-gastric Emptying

The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.

Time frame: Up to 8 weeks

Population: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects

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Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points

Part A: Albumin Level in Urine at Indicated Time Points

Part A: Assessment of Heart Rate (HR) as a Measure of Safety

Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score

Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score

Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety

Part A: Average Dominant Frequency

Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points

Part A: Concentration of Creatinine in Urine at Indicated Time Points

Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points

Part A: Distribution of Average Power by Frequency Region

Part A: Estimated Glomerular Filtration Rate at Indicated Time Points

Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score

Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels

Part A: Hematocrit Level at Indicated Time Points

Part A: Hemoglobin Level at Indicated Time Points

Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)

Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points

Part A: Number of Par. With Shifts in Gastric Rhythm Status

Part A: Number Par. by Gastric Rhythm Status

Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points

Part A: Presence RBC and WBC in Urine Assessed by Microscopy

Part A: Rate of [13]C Dose Excreted in Breath

Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

Part A: Red Blood Cell (RBC) Count at Indicated Time Points

Part A: Specific Gravity of Urine at Indicated Time Points

Part A: The Volume of Water Ingested During EGG

Part A: Time to Half-gastric Emptying

Part A: Total Protein, Albumin Levels at Indicated Time Points

Part B: Assessment of Nausea by VAS Score

Part B: Distribution of Average Power by Frequency Region

Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal

Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region

Part B: Assessment of GCSI-DD Score

Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score

Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters

Part B: Number of Par. With Abnormal Values for Hematology Parameters

Part B: Number of Par. With Abnormal Values for Urinalysis

Part B: Number of Par. With Abnormal Values for Vital Signs

Part B: Number of Par. With AEs and SAEs

Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD

Part B: Rate of [13]C Dose Excreted in Breath

Part B: The Volume of Water Ingested During EGG

Part B: Time to Half-gastric Emptying