Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Exantide with Dapagliflozin; Drug: Exentide; Drug: Dapagliflozin

• Registration Number: NCT02229396
• Lead Sponsor: AstraZeneca

Brief Summary

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-09-01
• Study Start: 2014-09-04
• Primary Completion: 2016-04-26
• Results First Submitted: 2017-08-09
• Results First Submitted QC: 2017-08-09
• Results First Posted: 2017-09-08
• Study Completion: 2017-12-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 695

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg	Exantide with Dapagliflozin	-
Exenatide Once Weekly 2 mg Alone	Exentide	-
Dapagliflozin Once Daily 10 mg Alone	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 28	Baseline to Week 28	To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight From Baseline to Week 28	Baseline to Week 28	To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Change in Fasting Plasma Glucose From Baseline to Week 2	Baseline to Week 2	To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Percentage of Patients Achieving HbA1c <7% at Week 28	Baseline to Week 28	To compare the percentage of patients achieving HbA1c \<7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Change in Systolic Blood Pressure From Baseline to Week 28	Baseline to Week 28	To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Change in Fasting Plasma Glucose From Baseline to Week 28	Baseline to Week 28	To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test	Baseline to Week 28	To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28	Baseline to Week 28	To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

Trial Locations

Locations (1)

Research Site; 🇿🇦 Pretoria, South Africa