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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Exenatide once weekly suspension 2mg subcutaneous injection

Overencapsulated Sitagliptin 100mg oral tablet once daily

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

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

Research Site

Reseach Site

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

Age Continuous

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

Weight

Study Specific Characteristic

Baseline HbA1c

HbA1c Stratum

Fasting Plasma Glucose

Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.

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.

Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28

Baseline Yes

Baseline No

Week 28 Yes

Week 28 No

Proportions of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.

Percentage of Subjects Achieving HbA1c <7% at Week 28.

Percentage of Subjects Achieving HbA1c <7% at Week 28

The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.

Change in fasting plasma glucose concentrations from Baseline to Week 28

The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.

Change in body weight (kg) from baseline to Week 28

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.

Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.

Change in 2-hour postprandial glucose concentrations from baseline to Week 16 (Visit 8)

Overall Study

Subjects were randomly assigned across 3 treatment groups (exenatide, sitagliptin, and placebo) in a ratio of 3:2:1, with randomization stratified by screening HbA1c stratum (< 9% or 9%).

Arms	Assigned Interventions
Experimental: Exenatide once weekly suspension Exenatide once weekly suspension 2mg subcutaneous injection	-
Active Comparator: Sitagliptin 100mg Overencapsulated Sitagliptin 100mg oral tablet once daily	-
Placebo Comparator: Placebo Placebo oral capsule once daily	Drug: Placebo Placebo oral capsule once daily

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

BCB120_Synopsis

Contacts

Contact

Investigators

Principal Investigator