Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00676338
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 820
- have type 2 diabetes and are treated with diet and exercise alone.
- at least 18 years of age.
- HbA1c between 7.1% and 11.0%, inclusive.
- Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
- Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
- Have a history of renal transplantation or are currently receiving renal dialysis
- Have 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 history of severe GI disorder (e.g., gastroparesis)
- Have a history of acute or chronic pancreatitis.
- Have active proliferative retinopathy.
- Have been treated with drugs that promote weight loss (e.g., Xenical®[orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
- Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
- Have had an organ transplant.
- Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
- 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.
- Are currently enrolled in any other clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide Once Weekly exenatide once weekly - Metformin metformin - Sitagliptin sitagliptin - Pioglitazone pioglitazone -
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 26 Baseline, Week 26 Change in HbA1c from baseline to Week 26.
Percentage of Patients Achieving HbA1c <=7% at Week 26 Baseline, Week 26 Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%).
- Secondary Outcome Measures
Name Time Method Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 Baseline, Week 26 Change in FSG from baseline to Week 26.
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26 Baseline, Week 26 Change in Fasting TC from baseline to Week 26.
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26 Baseline, Week 26 Change in Fasting HDL from baseline to Week 26.
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events Baseline to Week 26 Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Change in Systolic Blood Pressure From Baseline to Week 26. Baseline, Week 26 Change in Systolic Blood Pressure from baseline to Week 26.
Change in Diastolic Blood Pressure From Baseline to Week 26. Baseline, Week 26 Change in Diastolic Blood Pressure from baseline to Week 26.
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events Baseline to Week 26 Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Change in Body Weight From Baseline to Week 26 Baseline, Week 26 Change in Body Weight from baseline to Week 26.
Ratio of Fasting Triglycerides at Week 26 to Baseline Baseline, Week 26 Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Trial Locations
- Locations (2)
Research Site
🇬🇧Swansea, United Kingdom
Research SIte
🇮🇱Tel-Hashomer, Israel