Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)
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|ClinicalTrials.gov Identifier: NCT01652729|
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : April 23, 2015
Last Update Posted : August 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Type 2||Drug: Exenatide once weekly suspension Drug: Sitagliptin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Exenatide once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
Drug: Exenatide once weekly suspension
Active Comparator: Sitagliptin 100mg
Overencapsulated Sitagliptin 100mg oral tablet once daily
Placebo Comparator: Placebo
Placebo oral capsule once daily
Placebo oral capsule once daily
- Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
- Percentage of Subjects Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.
- Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
- Change in Body Weight (kg) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
- Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) [ Time Frame: Baseline to Week 16 ]The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652729
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|Study Chair:||Peter Ohman||AstraZeneca|