Type 2 Diabetes
Conditions
Keywords
Exenatide, Amylin, Lilly, Byetta, Exenatide Once Weekly
Brief summary
The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.
Interventions
subcutaneous injection, 2 mg, once a week
DRUGexenatide once monthly suspension
subcutaneous injection, low dose, once a month
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years old at study start * Has been diagnosed with type 2 diabetes mellitus * Has HbA1c of 7.1% to 11.0%, inclusive, at study start * Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start * Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents
Exclusion criteria
* Clinically significant medical condition that could potentially affect study participation including: * Acute or chronic pancreatitis * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2 * Active cardiovascular disease within 3 months of study start * Underlying hepatic or renal disease * Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery) * Has had \> 2 episodes of major hypoglycemia in the preceding 6 months before study start * Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start * Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications: * Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist * Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start * Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start * Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start * Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption * Prescription or over-the-counter weight loss medications within 3 months prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Baseline (Day 1) to 20 weeks | HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Baseline (Day 1) to Week 20 | Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug. |
| Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Baseline (Day 1) to Week 20 | Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug. |
| Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Day 1 to Week 20 | All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL). |
| Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Baseline (Day 1), Week 20 | Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug. |
| Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population | Baseline (Day 1), Week 20 | Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug. |
| Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | Week 20 | HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were \<7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug. |
| Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population | Day 1 through study termination (Week 24) or early termination. | AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth. Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19. . |
| Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Day 1 to Study Termination (24 weeks) or early termination | Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1. |
| Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Day 1 to study termination (24 weeks) or early termination | Potential clinical importance are the following: Hematocrit values for males less than (\<) 36%, females \< 30%; hemoglobin for males \<12 grams per deciliter (g/dL), females \< 10 g/dL; low platelet values \<75,000/micro liter (µL), high values greater than (\>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination. |
| Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Day 1 to Study Termination (Week24) or early termination | Potential clinical importance (PCI): triacylglycerol lipase high values were \> 3\* upper limit of normal (ULN); creatinine high values in males \>1.6 mg/dL, females \>1.4 mg/dL; gamma glutamyl transferase (GGT) high value \>3\* ULN; bilirubin high value \> 2 mg/dL; Urate high values \> 10 (males), \>8 (females) mg/dL; potassium low value \< 3 milliequivalents per liter (mEq/L), high value \>5.5 mEq/L; calcium low value \< 8 mg/dL and high value \> 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Day 1 to Study Termination (24 Weeks) or early Termination | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination. |
Countries
United States
Participant flow
Recruitment details
Study initiated 22-May-2010; completed 27-Dec-2010. Once weekly arm: first dose of exenatide administered at study-site on Day 1; self-administered on a weekly basis over subsequent 20 weeks. Once monthly arm: first dose of exenatide administered at study-site on Day 1;self-administered on monthly basis by participants over next 20 weeks.
Participants by arm
| Arm | Count |
|---|---|
| 2 mg Exenatide Weekly 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC). | 30 |
| 5 mg Exenatide Monthly 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. | 30 |
| 8 mg Exenatide Monthly 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. . | 31 |
| 11 mg Exenatide Monthly 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. | 30 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | 2 mg Exenatide Weekly | 5 mg Exenatide Monthly | 8 mg Exenatide Monthly | 11 mg Exenatide Monthly |
|---|---|---|---|---|---|
| Age, Customized Greater than, equal to (≥) 65 years of age | 11 participants | 2 participants | 1 participants | 5 participants | 3 participants |
| Age, Customized Less than (<) 65 years of age | 110 participants | 28 participants | 29 participants | 26 participants | 27 participants |
| Category of HbA1c HbA1c < 9.0% | 78 participants | 20 participants | 18 participants | 19 participants | 21 participants |
| Category of HbA1c HbA1c ≥ 9.0% | 43 participants | 10 participants | 12 participants | 12 participants | 9 participants |
| Mean Hemoglobin A1c (HbA1c) | 8.52 Percent of hemoglobin STANDARD_DEVIATION 1.21 | 8.64 Percent of hemoglobin STANDARD_DEVIATION 1.19 | 8.54 Percent of hemoglobin STANDARD_DEVIATION 1.18 | 8.54 Percent of hemoglobin STANDARD_DEVIATION 1.18 | 8.37 Percent of hemoglobin STANDARD_DEVIATION 1.34 |
| Race/Ethnicity, Customized Asian | 3 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 12 participants | 1 participants | 4 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 104 participants | 28 participants | 24 participants | 29 participants | 23 participants |
| Region of Enrollment United States | 121 participants | 30 participants | 30 participants | 31 participants | 30 participants |
| Sex: Female, Male Female | 43 Participants | 10 Participants | 13 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 78 Participants | 20 Participants | 17 Participants | 24 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 30 | 25 / 30 | 20 / 31 | 24 / 30 |
| serious Total, serious adverse events | 0 / 30 | 2 / 30 | 0 / 31 | 0 / 30 |
Outcome results
Primary
Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population
HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time frame: Baseline (Day 1) to 20 weeks
Population: All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Exenatide Weekly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 16 (n=29, 26, 28, 27) | -1.58 Percent of Hemoglobin | Standard Error 0.216 |
| 2 mg Exenatide Weekly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 8 (n=25, 22, 25, 27) | -1.15 Percent of Hemoglobin | Standard Error 0.157 |
| 2 mg Exenatide Weekly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 20 (n=29, 26, 28, 27) | -1.54 Percent of Hemoglobin | Standard Error 0.234 |
| 2 mg Exenatide Weekly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 12 (n=29, 26, 28, 27) | -1.43 Percent of Hemoglobin | Standard Error 0.223 |
| 2 mg Exenatide Weekly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 4 (n=29, 26, 28, 27) | -0.52 Percent of Hemoglobin | Standard Error 0.095 |
| 5 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 12 (n=29, 26, 28, 27) | -1.30 Percent of Hemoglobin | Standard Error 0.209 |
| 5 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 16 (n=29, 26, 28, 27) | -1.40 Percent of Hemoglobin | Standard Error 0.215 |
| 5 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 20 (n=29, 26, 28, 27) | -1.29 Percent of Hemoglobin | Standard Error 0.21 |
| 5 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 8 (n=25, 22, 25, 27) | -0.89 Percent of Hemoglobin | Standard Error 0.2 |
| 5 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 4 (n=29, 26, 28, 27) | -0.33 Percent of Hemoglobin | Standard Error 0.127 |
| 8 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 12 (n=29, 26, 28, 27) | -1.19 Percent of Hemoglobin | Standard Error 0.246 |
| 8 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 4 (n=29, 26, 28, 27) | -0.24 Percent of Hemoglobin | Standard Error 0.139 |
| 8 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 8 (n=25, 22, 25, 27) | -1.03 Percent of Hemoglobin | Standard Error 0.218 |
| 8 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 16 (n=29, 26, 28, 27) | -1.41 Percent of Hemoglobin | Standard Error 0.271 |
| 8 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 20 (n=29, 26, 28, 27) | -1.31 Percent of Hemoglobin | Standard Error 0.313 |
| 11 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 16 (n=29, 26, 28, 27) | -1.43 Percent of Hemoglobin | Standard Error 0.177 |
| 11 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 8 (n=25, 22, 25, 27) | -0.91 Percent of Hemoglobin | Standard Error 0.11 |
| 11 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 4 (n=29, 26, 28, 27) | -0.34 Percent of Hemoglobin | Standard Error 0.074 |
| 11 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 12 (n=29, 26, 28, 27) | -1.26 Percent of Hemoglobin | Standard Error 0.156 |
| 11 mg Exenatide Monthly | Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population | Change from baseline at Week 20 (n=29, 26, 28, 27) | -1.45 Percent of Hemoglobin | Standard Error 0.179 |
Secondary
Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population
Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.
Time frame: Baseline (Day 1), Week 20
Population: Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Exenatide Weekly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Diastolic Blood Pressure | -1.7 mmHg | Standard Deviation 8.55 |
| 2 mg Exenatide Weekly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Systolic Blood Pressure | -2.3 mmHg | Standard Deviation 13.64 |
| 5 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Systolic Blood Pressure | 4.4 mmHg | Standard Deviation 18.68 |
| 5 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Diastolic Blood Pressure | 3.4 mmHg | Standard Deviation 8.54 |
| 8 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Diastolic Blood Pressure | 1.8 mmHg | Standard Deviation 9.61 |
| 8 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Systolic Blood Pressure | 0.5 mmHg | Standard Deviation 13.97 |
| 11 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Diastolic Blood Pressure | 1.9 mmHg | Standard Deviation 8.17 |
| 11 mg Exenatide Monthly | Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population | Systolic Blood Pressure | 5.0 mmHg | Standard Deviation 12.04 |
Secondary
Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population
Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.
Time frame: Baseline (Day 1), Week 20
Population: Participants who received at least one dose of study drug were analyzed in the ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2 mg Exenatide Weekly | Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population | 2.8 bpm | Standard Deviation 9.58 |
| 5 mg Exenatide Monthly | Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population | 3.9 bpm | Standard Deviation 10.69 |
| 8 mg Exenatide Monthly | Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population | 5.6 bpm | Standard Deviation 10.84 |
| 11 mg Exenatide Monthly | Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population | -0.3 bpm | Standard Deviation 11.55 |
Secondary
Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population
Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time frame: Baseline (Day 1) to Week 20
Population: All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 16 (n=29,26,28,27) | -1.85 kg | Standard Error 0.59 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -1.36 kg | Standard Error 0.641 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 14 (n=29,26,28,27) | -1.91 kg | Standard Error 0.643 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29,26,28,27) | -0.31 kg | Standard Error 0.274 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 15 (n=29,26,28,26) | -1.84 kg | Standard Error 0.511 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=29,26,28,27) | -1.26 kg | Standard Error 0.359 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28,26,28,27) | -1.36 kg | Standard Error 0.455 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29,26,28,27) | -0.66 kg | Standard Error 0.321 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 17-19(n=29,26,28,27) | -1.63 kg | Standard Error 0.592 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,28,27) | -1.73 kg | Standard Error 0.565 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 12 (n=28,26,28,27) | -1.49 kg | Standard Error 0.573 |
| 2 mg Exenatide Weekly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 13 (n=29,26,28,27) | -1.96 kg | Standard Error 0.505 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29,26,28,27) | -0.04 kg | Standard Error 0.249 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 13 (n=29,26,28,27) | -1.20 kg | Standard Error 0.572 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28,26,28,27) | -0.85 kg | Standard Error 0.395 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 15 (n=29,26,28,26) | -1.34 kg | Standard Error 0.648 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 16 (n=29,26,28,27) | -1.33 kg | Standard Error 0.673 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 14 (n=29,26,28,27) | -0.96 kg | Standard Error 0.611 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29,26,28,27) | 0.32 kg | Standard Error 0.232 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 12 (n=28,26,28,27) | -0.91 kg | Standard Error 0.453 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,28,27) | -0.57 kg | Standard Error 0.469 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=29,26,28,27) | -0.74 kg | Standard Error 0.304 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -1.10 kg | Standard Error 0.774 |
| 5 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 17-19(n=29,26,28,27) | -1.17 kg | Standard Error 0.697 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 14 (n=29,26,28,27) | -0.76 kg | Standard Error 0.589 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29,26,28,27) | 0.31 kg | Standard Error 0.234 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29,26,28,27) | 0.32 kg | Standard Error 0.299 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=29,26,28,27) | -0.45 kg | Standard Error 0.409 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28,26,28,27) | -0.33 kg | Standard Error 0.482 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,28,27) | -0.49 kg | Standard Error 0.498 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 12 (n=28,26,28,27) | -0.33 kg | Standard Error 0.578 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 13 (n=29,26,28,27) | -0.56 kg | Standard Error 0.591 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 15 (n=29,26,28,26) | -0.80 kg | Standard Error 0.581 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 16 (n=29,26,28,27) | -0.26 kg | Standard Error 0.551 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 17-19(n=29,26,28,27) | -0.58 kg | Standard Error 0.629 |
| 8 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -0.41 kg | Standard Error 0.559 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 12 (n=28,26,28,27) | -0.76 kg | Standard Error 0.502 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,28,27) | -0.83 kg | Standard Error 0.563 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29,26,28,27) | 0.35 kg | Standard Error 0.204 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 16 (n=29,26,28,27) | -1.02 kg | Standard Error 0.574 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28,26,28,27) | -0.70 kg | Standard Error 0.466 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=29,26,28,27) | -0.74 kg | Standard Error 0.326 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -1.14 kg | Standard Error 0.676 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 17-19(n=29,26,28,27) | -1.72 kg | Standard Error 0.7 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 14 (n=29,26,28,27) | -0.81 kg | Standard Error 0.563 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 13 (n=29,26,28,27) | -0.97 kg | Standard Error 0.551 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29,26,28,27) | 0.03 kg | Standard Error 0.226 |
| 11 mg Exenatide Monthly | Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 15 (n=29,26,28,26) | -1.24 kg | Standard Error 0.581 |
Secondary
Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population
Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time frame: Baseline (Day 1) to Week 20
Population: All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 13 (n=29,26,28,27) | -42.0 mg/dL | Standard Error 8.6 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 16 (n=29,26,28,27) | -34.5 mg/dL | Standard Error 9.96 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 14 (n=29,26,28,27) | -36.3 mg/dL | Standard Error 10.51 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=28, 26, 28,27) | -32.8 mg/dL | Standard Error 8.58 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 15 (n=29,26,28,26) | -38.0 mg/dL | Standard Error 11.09 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29, 26, 28,27) | -1.16 mg/dL | Standard Error 8.54 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -34.2 mg/dL | Standard Error 8.99 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28, 26, 28,27) | -40.8 mg/dL | Standard Error 8.7 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29, 25, 28,27) | -21.7 mg/dL | Standard Error 7.97 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,27,27) | -32.8 mg/dL | Standard Error 8.77 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks17-19 (n=29,26,28,27) | -33.3 mg/dL | Standard Error 8.58 |
| 2 mg Exenatide Weekly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 12 (n=29,26,27,27) | -44.8 mg/dL | Standard Error 10.28 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29, 26, 28,27) | -12.9 mg/dL | Standard Error 7.57 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 13 (n=29,26,28,27) | -38.0 mg/dL | Standard Error 7.52 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -25.1 mg/dL | Standard Error 8.49 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28, 26, 28,27) | -45.7 mg/dL | Standard Error 6.44 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 16 (n=29,26,28,27) | -31.6 mg/dL | Standard Error 9.24 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 14 (n=29,26,28,27) | -37.3 mg/dL | Standard Error 7.75 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks17-19 (n=29,26,28,27) | -42.4 mg/dL | Standard Error 7.16 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 15 (n=29,26,28,26) | -37.3 mg/dL | Standard Error 7.65 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 12 (n=29,26,27,27) | -37.4 mg/dL | Standard Error 8.61 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=28, 26, 28,27) | -42.6 mg/dL | Standard Error 5.72 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,27,27) | -40.2 mg/dL | Standard Error 8.25 |
| 5 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29, 25, 28,27) | -18.0 mg/dL | Standard Error 5.96 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 16 (n=29,26,28,27) | -43.3 mg/dL | Standard Error 10.14 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29, 26, 28,27) | -14.6 mg/dL | Standard Error 6.36 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29, 25, 28,27) | -14.2 mg/dL | Standard Error 8.57 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=28, 26, 28,27) | -39.5 mg/dL | Standard Error 9.49 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28, 26, 28,27) | -36.8 mg/dL | Standard Error 7.45 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,27,27) | -44.3 mg/dL | Standard Error 7.71 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 12 (n=29,26,27,27) | -45.4 mg/dL | Standard Error 6.78 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 13 (n=29,26,28,27) | -48.6 mg/dL | Standard Error 6.21 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 14 (n=29,26,28,27) | -47.5 mg/dL | Standard Error 7.83 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 15 (n=29,26,28,26) | -46.9 mg/dL | Standard Error 7.35 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks17-19 (n=29,26,28,27) | -34.6 mg/dL | Standard Error 9.32 |
| 8 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -29.8 mg/dL | Standard Error 9.88 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 13 (n=29,26,28,27) | -45.7 mg/dL | Standard Error 8.6 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 12 (n=29,26,27,27) | -44.9 mg/dL | Standard Error 7.53 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 16 (n=29,26,28,27) | -46.3 mg/dL | Standard Error 7.9 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 9-11 (n=29,26,27,27) | -48.1 mg/dL | Standard Error 7.6 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 8 (n=28, 26, 28,27) | -44.0 mg/dL | Standard Error 7.24 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 20 (n=29,26,28,27) | -48.9 mg/dL | Standard Error 9.35 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks17-19 (n=29,26,28,27) | -55.1 mg/dL | Standard Error 8.92 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 6 (n=28, 26, 28,27) | -48.8 mg/dL | Standard Error 7.67 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 4 (n=29, 25, 28,27) | -23.1 mg/dL | Standard Error 7.83 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 14 (n=29,26,28,27) | -51.6 mg/dL | Standard Error 8.68 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Week 2 (n=29, 26, 28,27) | -23.5 mg/dL | Standard Error 5.17 |
| 11 mg Exenatide Monthly | Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population | Change from baseline to Weeks 15 (n=29,26,28,26) | -53.1 mg/dL | Standard Error 8.96 |
Secondary
Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
Potential clinical importance (PCI): triacylglycerol lipase high values were \> 3\* upper limit of normal (ULN); creatinine high values in males \>1.6 mg/dL, females \>1.4 mg/dL; gamma glutamyl transferase (GGT) high value \>3\* ULN; bilirubin high value \> 2 mg/dL; Urate high values \> 10 (males), \>8 (females) mg/dL; potassium low value \< 3 milliequivalents per liter (mEq/L), high value \>5.5 mEq/L; calcium low value \< 8 mg/dL and high value \> 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.
Time frame: Day 1 to Study Termination (Week24) or early termination
Population: All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 12 (n=30,29,29,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 12 (n=30,29,30,28) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 6 (n=30,30,30,30) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine at study termination (n=30,26,29,28) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 12 (n=30,29,30,28) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 12 (n=30,29,30,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Study termination (n=30,26,29,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 6 (n=30,30,30,30) | 2 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 6 (n=30,30,30,30) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Calcium Week 6 (n=30,30,30,30) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 20 (n=30,27,29,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 20 (n=30,26,28,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Potassium Week 6 (n=30,30,30,30) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 6 (n=30,30,30,30) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 20 (n=30,26,28,28) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT study termination (n=30,26,29,28) | 1 laboratory values |
| 2 mg Exenatide Weekly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 20 (n=30,26,28,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT study termination (n=30,26,29,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 12 (n=30,29,30,28) | 3 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 6 (n=30,30,30,30) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Calcium Week 6 (n=30,30,30,30) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 12 (n=30,29,30,28) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 6 (n=30,30,30,30) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Potassium Week 6 (n=30,30,30,30) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 12 (n=30,29,30,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 20 (n=30,26,28,28) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 20 (n=30,27,29,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Study termination (n=30,26,29,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine at study termination (n=30,26,29,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 12 (n=30,29,29,28) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 6 (n=30,30,30,30) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 20 (n=30,26,28,28) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 20 (n=30,26,28,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 6 (n=30,30,30,30) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 12 (n=30,29,30,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 12 (n=30,29,29,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 20 (n=30,27,29,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 6 (n=30,30,30,30) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 12 (n=30,29,30,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 20 (n=30,26,28,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine at study termination (n=30,26,29,28) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 6 (n=30,30,30,30) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 20 (n=30,26,28,28) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT study termination (n=30,26,29,28) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 6 (n=30,30,30,30) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 6 (n=30,30,30,30) | 2 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 12 (n=30,29,30,28) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 20 (n=30,26,28,28) | 2 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Study termination (n=30,26,29,28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Potassium Week 6 (n=30,30,30,30) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Calcium Week 6 (n=30,30,30,30) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 12 (n=30,29,30,28) | 2 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 20 (n=30,26,28,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT Week 6 (n=30,30,30,30) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 20 (n=30,27,29,28) | 1 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 20 (n=30,26,28,28) | 2 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine at study termination (n=30,26,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 20 (n=30,26,28,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | triacylglycerol lipase Week 12 (n=30,29,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Study termination (n=30,26,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 12 (n=30,29,30,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Creatinine Week 6 (n=30,30,30,30) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 12 (n=30,29,30,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Calcium Week 6 (n=30,30,30,30) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Urate Week 6 (n=30,30,30,30) | 2 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Bilirubin Week 6 (n=30,30,30,30) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | GGT study termination (n=30,26,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Potassium Week 6 (n=30,30,30,30) | 0 laboratory values |
Secondary
Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
Potential clinical importance are the following: Hematocrit values for males less than (\<) 36%, females \< 30%; hemoglobin for males \<12 grams per deciliter (g/dL), females \< 10 g/dL; low platelet values \<75,000/micro liter (µL), high values greater than (\>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.
Time frame: Day 1 to study termination (24 weeks) or early termination
Population: n= all participants who received at least one dose of study drug and had available laboratory measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg Exenatide Weekly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 12 Platelets (n=30, 29, 30, 28) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 6 Hematocrit (n=30,30,30,30) | 0 laboratory values |
| 2 mg Exenatide Weekly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Hematocrit at study termination (n=30,27,29,28) | 0 laboratory values |
| 5 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 6 Hematocrit (n=30,30,30,30) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 12 Platelets (n=30, 29, 30, 28) | 1 laboratory values |
| 5 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Hematocrit at study termination (n=30,27,29,28) | 1 laboratory values |
| 8 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 12 Platelets (n=30, 29, 30, 28) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 6 Hematocrit (n=30,30,30,30) | 0 laboratory values |
| 8 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Hematocrit at study termination (n=30,27,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Hematocrit at study termination (n=30,27,29,28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 12 Platelets (n=30, 29, 30, 28) | 0 laboratory values |
| 11 mg Exenatide Monthly | Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population | Week 6 Hematocrit (n=30,30,30,30) | 0 laboratory values |
Secondary
Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population
AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth. Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19. .
Time frame: Day 1 through study termination (Week 24) or early termination.
Population: All participants who received at least one dose of study drug were analyzed in the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 mg Exenatide Weekly | Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population | 6 participants |
| 5 mg Exenatide Monthly | Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population | 8 participants |
| 8 mg Exenatide Monthly | Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population | 3 participants |
| 11 mg Exenatide Monthly | Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population | 6 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.
Time frame: Day 1 to Study Termination (24 Weeks) or early Termination
Population: All participants who received at least one dose of study drug were included in the ITT analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg Exenatide Weekly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AES | 27 participants |
| 2 mg Exenatide Weekly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AEs Leading to Discontinuation | 0 participants |
| 2 mg Exenatide Weekly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent SAEs | 0 participants |
| 5 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AES | 25 participants |
| 5 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AEs Leading to Discontinuation | 0 participants |
| 5 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent SAEs | 2 participants |
| 8 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent SAEs | 0 participants |
| 8 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AES | 20 participants |
| 8 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AEs Leading to Discontinuation | 0 participants |
| 11 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AES | 24 participants |
| 11 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent AEs Leading to Discontinuation | 1 participants |
| 11 mg Exenatide Monthly | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population | Treatment-Emergent SAEs | 0 participants |
Secondary
Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population
Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.
Time frame: Day 1 to Study Termination (24 weeks) or early termination
Population: n=all participants who received at least one dose of study drug and had available titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Negative (n=30,30,30,30) | 27 participants |
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Low Titer (<625)(n=30,30,30,30) | 3 participants |
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 High Titer (≥625)(n=30,30,30,30) | 0 participants |
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Negative (n=30,26,29,28) | 7 participants |
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Low Titer (<625)(n=30,26,29,28) | 15 participants |
| 2 mg Exenatide Weekly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 High Titer (≥625)(n=30,26,29,28) | 8 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 High Titer (≥625)(n=30,26,29,28) | 8 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Negative (n=30,26,29,28) | 8 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Negative (n=30,30,30,30) | 30 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 High Titer (≥625)(n=30,30,30,30) | 0 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Low Titer (<625)(n=30,30,30,30) | 0 participants |
| 5 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Low Titer (<625)(n=30,26,29,28) | 10 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Low Titer (<625)(n=30,30,30,30) | 0 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 High Titer (≥625)(n=30,30,30,30) | 0 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Negative (n=30,26,29,28) | 9 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 High Titer (≥625)(n=30,26,29,28) | 5 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Low Titer (<625)(n=30,26,29,28) | 15 participants |
| 8 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Negative (n=30,30,30,30) | 30 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Low Titer (<625)(n=30,26,29,28) | 15 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 High Titer (≥625)(n=30,26,29,28) | 4 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Low Titer (<625)(n=30,30,30,30) | 1 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 20 Negative (n=30,26,29,28) | 9 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 Negative (n=30,30,30,30) | 29 participants |
| 11 mg Exenatide Monthly | Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population | Week 2 High Titer (≥625)(n=30,30,30,30) | 0 participants |
Secondary
Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population
HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were \<7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time frame: Week 20
Population: All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg Exenatide Weekly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | < 7.0% HbA1c | 48.3 percentage of Participants |
| 2 mg Exenatide Weekly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | ≤ 6.5% HbA1c | 44.8 percentage of Participants |
| 5 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | ≤ 6.5% HbA1c | 26.9 percentage of Participants |
| 5 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | < 7.0% HbA1c | 50.0 percentage of Participants |
| 8 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | < 7.0% HbA1c | 57.1 percentage of Participants |
| 8 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | ≤ 6.5% HbA1c | 39.3 percentage of Participants |
| 11 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | < 7.0% HbA1c | 70.4 percentage of Participants |
| 11 mg Exenatide Monthly | Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population | ≤ 6.5% HbA1c | 48.1 percentage of Participants |
Secondary
Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population
All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).
Time frame: Day 1 to Week 20
Population: PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Exenatide Weekly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Cave(2016-2688h) pg/mL | 262.92 pg/mL | Geometric Coefficient of Variation 83.54 |
| 2 mg Exenatide Weekly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Peak-Trough (2016-2688h) pg/mL | 171.27 pg/mL | Geometric Coefficient of Variation 73.85 |
| 5 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Peak-Trough (2016-2688h) pg/mL | 198.06 pg/mL | Geometric Coefficient of Variation 86.76 |
| 5 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Cave(2016-2688h) pg/mL | 127.13 pg/mL | Geometric Coefficient of Variation 69.34 |
| 8 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Cave(2016-2688h) pg/mL | 247.38 pg/mL | Geometric Coefficient of Variation 81.63 |
| 8 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Peak-Trough (2016-2688h) pg/mL | 424.47 pg/mL | Geometric Coefficient of Variation 70.27 |
| 11 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Cave(2016-2688h) pg/mL | 218.07 pg/mL | Geometric Coefficient of Variation 73.77 |
| 11 mg Exenatide Monthly | Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population | Peak-Trough (2016-2688h) pg/mL | 328.52 pg/mL | Geometric Coefficient of Variation 86.3 |