Phase 3
Completed N=820
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)
Source: ClinicalTrials.gov NCT00676338 ↗Enrolled (actual)
820
Serious AEs
3.4%
Results posted
Nov 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -1.53; -1.48; -1.63; -1.15 percentage of total hemoglobin — p=0.620
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-1.53; -1.48; -1.63; -1.15 | 0.620 |
| PRIMARY Percentage of Patients Achieving HbA1c <=7% at Week 26 |
64.2; 57.3; 63.3; 45.5 | 0.151 |
| SECONDARY Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 |
-2.25; -1.98; -2.57; -1.13 | 0.155 |
| SECONDARY Change in Body Weight From Baseline to Week 26 |
-2.04; -2.00; 1.52; -0.76 | 0.892 |
| SECONDARY Change in Fasting Total Cholesterol (TC) From Baseline to Week 26 |
-0.24; -0.22; 0.09; -0.01 | 0.873 |
| SECONDARY Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26 |
0.01; 0.07; 0.17; 0.04 | 0.004 sig |
| SECONDARY Ratio of Fasting Triglycerides at Week 26 to Baseline |
0.98; 0.96; 0.85; 0.94 | 0.657 |
| SECONDARY Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events |
0.05; 0.00; 0.00; 0.00 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 26. |
-1.25; 0.14; -1.74; -1.81 | 0.201 |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Week 26. |
-0.50; -0.86; -2.50; -0.45 | 0.610 |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00676338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.