Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, sitagliptin, Amylin, Lilly, metformin, thiazolidinedione
Brief summary
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
Interventions
DRUGexenatide
subcutaneous injection (5mcg or 10mcg), twice a day
DRUGsitagliptin
oral administration (100mg), once a day in the morning
DRUGplacebo
subcutaneous injection (5mcg or 10mcg), twice a day
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes * Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1. * Have a fasting glucose concentration \<280 mg/dL at Visit 1 * Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening. * Are between 18 and 70 years of age, inclusive. * Have body mass index ≥25 kg/m2 and ≤45 kg/m2. * Have a history of stable body weight (not varying by \>10% for at least 3 months prior to screening). * Can swallow oral study drug capsule, without splitting or crushing.
Exclusion criteria
* Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria: * Are breastfeeding. * Test positive for pregnancy at the time of screening. * Intend to become pregnant during the study. * Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening. * Treated with any of the following medications: * Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening * Alpha-glucosidase inhibitor within 2 months of screening. * Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics. * Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1. * Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening. * Have a history of renal transplantation or are currently receiving renal dialysis. * Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis. * Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months. * Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. * Have had organ transplantation. * Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time-averaged Glucose During a 24 Hour Period | baseline and 8 Weeks | Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose After the Morning Meal | baseline and 8 Weeks | Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint) |
| Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal | baseline and 8 Weeks | Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint) |
| Change in Postprandial Glucagon AUC Excursion After the Morning Meal | baseline and 8 Weeks | Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint) |
| Change in Postprandial Triglyceride AUC After the Morning Meal | baseline and 8 Weeks | Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint) |
| Change in Postprandial Triglyceride AUC Excursion After the Morning Meal | baseline and 8 Weeks | Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint) |
| Change in Postprandial C-peptide AUC After the Morning Meal | baseline and 8 Weeks | Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint) |
| Change in Postprandial C-peptide AUC Excursion After the Morning Meal | baseline and 8 Weeks | Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint) |
| Change in Postprandial Insulin AUC After the Morning Meal | baseline and 8 Weeks | Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint) |
| Change in Two-hour Postprandial Glucose After the Morning Meal | baseline and 8 Weeks | Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint) |
| Change in Postprandial Active GLP-1 AUC After the Morning Meal | baseline and 8 Weeks | Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint) |
| Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal | baseline and 8 Weeks | Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint) |
| Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4) | 4 Weeks | Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL |
| Episodes of Hypoglycemia (Baseline to Week 4) | 4 weeks | Number of episodes of hypoglycemia experienced during the first 4 weeks of the study |
| Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8) | 8 weeks | Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL |
| Episodes of Hypoglycemia (Week 4 to Week 8) | 8 weeks | Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study |
| Percentage of Patients Experiencing Hypoglycemia (Overall) | 4 weeks and 8 weeks | Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL |
| Episodes of Hypoglycemia (Overall) | 4 weeks and 8 weeks | Number of episodes of hypoglycemia experienced overall during the study |
| Change in Postprandial Insulin AUC Excursion After the Morning Meal | baseline and 8 Weeks | Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exenatide Followed By Sitagliptin Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. | 41 |
| Sitagliptin Followed By Exenatide Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Sponsor Decision | 1 | 2 |
| Overall Study | Subject Decision | 4 | 4 |
Baseline characteristics
| Characteristic | Exenatide Followed By Sitagliptin | Sitagliptin Followed By Exenatide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 37 Participants | 71 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.1 | 53.5 years STANDARD_DEVIATION 9.49 | 54.1 years STANDARD_DEVIATION 9.75 |
| Sex: Female, Male Female | 19 Participants | 29 Participants | 48 Participants |
| Sex: Female, Male Male | 22 Participants | 13 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 73 | 37 / 73 |
| serious Total, serious adverse events | 2 / 73 | 0 / 73 |
Outcome results
Primary
Change in Time-averaged Glucose During a 24 Hour Period
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
Time frame: baseline and 8 Weeks
Population: The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Time-averaged Glucose During a 24 Hour Period | -41.65 mg/dL | Standard Error 2.55 |
| Sitagliptin | Change in Time-averaged Glucose During a 24 Hour Period | -29.56 mg/dL | Standard Error 2.58 |
Comparison: Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.p-value: <0.001ANCOVA
Secondary
Change in Fasting Blood Glucose After the Morning Meal
Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Fasting Blood Glucose After the Morning Meal | -28.93 mg/dL | Standard Error 2.7 |
| Sitagliptin | Change in Fasting Blood Glucose After the Morning Meal | -28.22 mg/dL | Standard Error 2.71 |
p-value: 0.766ANCOVA
Secondary
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Active GLP-1 AUC After the Morning Meal | -14.28 pmol*hours/L | Standard Error 3.12 |
| Sitagliptin | Change in Postprandial Active GLP-1 AUC After the Morning Meal | 47.37 pmol*hours/L | Standard Error 3.15 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal | -14.04 pmol*hours/L | Standard Error 3.28 |
| Sitagliptin | Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal | 23.53 pmol*hours/L | Standard Error 3.31 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial C-peptide AUC After the Morning Meal
Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial C-peptide AUC After the Morning Meal | -1.78 nmol*hours/L | Standard Error 0.28 |
| Sitagliptin | Change in Postprandial C-peptide AUC After the Morning Meal | 0.25 nmol*hours/L | Standard Error 0.28 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial C-peptide AUC Excursion After the Morning Meal | -2.83 nmol*hours/L | Standard Error 0.29 |
| Sitagliptin | Change in Postprandial C-peptide AUC Excursion After the Morning Meal | 0.14 nmol*hours/L | Standard Error 0.29 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal | -29.60 pmol*hours/L | Standard Error 2.91 |
| Sitagliptin | Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal | -16.91 pmol*hours/L | Standard Error 2.93 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Glucagon AUC Excursion After the Morning Meal | -30.94 pmol*hours/L | Standard Error 2.12 |
| Sitagliptin | Change in Postprandial Glucagon AUC Excursion After the Morning Meal | -14.93 pmol*hours/L | Standard Error 2.13 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Insulin AUC After the Morning Meal
Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Insulin AUC After the Morning Meal | -396.12 pmol*hours/L | Standard Error 56.79 |
| Sitagliptin | Change in Postprandial Insulin AUC After the Morning Meal | -8.79 pmol*hours/L | Standard Error 57.32 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Insulin AUC Excursion After the Morning Meal | -525.01 pmol*hours/L | Standard Error 58.77 |
| Sitagliptin | Change in Postprandial Insulin AUC Excursion After the Morning Meal | -34.83 pmol*hours/L | Standard Error 59.4 |
p-value: <0.001ANCOVA
Secondary
Change in Postprandial Triglyceride AUC After the Morning Meal
Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Triglyceride AUC After the Morning Meal | 0.83 mg*hours/dL | Standard Error 0.03 |
| Sitagliptin | Change in Postprandial Triglyceride AUC After the Morning Meal | 0.87 mg*hours/dL | Standard Error 0.03 |
p-value: 0.117ANCOVA
Secondary
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Postprandial Triglyceride AUC Excursion After the Morning Meal | -108.16 mg*hours/dL | Standard Error 8.38 |
| Sitagliptin | Change in Postprandial Triglyceride AUC Excursion After the Morning Meal | -41.39 mg*hours/dL | Standard Error 8.45 |
p-value: <0.001ANCOVA
Secondary
Change in Two-hour Postprandial Glucose After the Morning Meal
Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Population: All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide | Change in Two-hour Postprandial Glucose After the Morning Meal | -108.35 mg/dL | Standard Error 4.36 |
| Sitagliptin | Change in Two-hour Postprandial Glucose After the Morning Meal | -44.43 mg/dL | Standard Error 4.4 |
p-value: <0.001ANCOVA
Secondary
Episodes of Hypoglycemia (Baseline to Week 4)
Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
Time frame: 4 weeks
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Episodes of Hypoglycemia (Baseline to Week 4) | 1 episodes of hypoglycemia |
| Sitagliptin | Episodes of Hypoglycemia (Baseline to Week 4) | 1 episodes of hypoglycemia |
Secondary
Episodes of Hypoglycemia (Overall)
Number of episodes of hypoglycemia experienced overall during the study
Time frame: 4 weeks and 8 weeks
Population: All patients in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Episodes of Hypoglycemia (Overall) | 3 episodes of hypoglycemia |
| Sitagliptin | Episodes of Hypoglycemia (Overall) | 1 episodes of hypoglycemia |
Secondary
Episodes of Hypoglycemia (Week 4 to Week 8)
Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
Time frame: 8 weeks
Population: All patients in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Episodes of Hypoglycemia (Week 4 to Week 8) | 2 episodes of hypoglycemia |
| Sitagliptin | Episodes of Hypoglycemia (Week 4 to Week 8) | 0 episodes of hypoglycemia |
Secondary
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 4 Weeks
Population: All patients in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4) | 2.9 Percentage of patients |
| Sitagliptin | Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4) | 2.7 Percentage of patients |
Secondary
Percentage of Patients Experiencing Hypoglycemia (Overall)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 4 weeks and 8 weeks
Population: All patients in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Experiencing Hypoglycemia (Overall) | 4.3 Percentage of patients |
| Sitagliptin | Percentage of Patients Experiencing Hypoglycemia (Overall) | 1.4 Percentage of patients |
Secondary
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 8 weeks
Population: All patients in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide | Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8) | 5.7 Percentage of patients |
| Sitagliptin | Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8) | 0.0 Percentage of patients |