Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Exenatide once weekly suspension; Drug: Exenatide twice daily

• Registration Number: NCT01652716
• Lead Sponsor: AstraZeneca

Brief Summary

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

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Study Start: 2013-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-08-04
• Results First Submitted QC: 2015-08-18
• Results First Posted: 2015-09-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• At least 18 years old
• Diagnosed with type 2 diabetes mellitus
• HbA1c 7.1 to 11%, inclusive, at screening
• Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
• Body mass index (BMI) <=45 kg/m2, inclusive, at screening
• Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria

• History of pancreatitis or triglycerides >=500 mg/dL
• Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
• Active cardiovascular disease
• Presence of congestive heart failure
• Liver disease
• History of severe gastrointestinal diseases
• Repeated severe hypoglycemia within the last 6 months
• Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
• Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide once weekly suspension	Exenatide once weekly suspension	Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily (BID)	Exenatide twice daily	Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28	Baseline to Week 28	The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving HbA1c <7% at Week 28	Baseline to Week 28	Percentage of subjects achieving HbA1c \<7% at Week 28/Study Termination
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28	Baseline to Week 28	Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Change in Body Weight (kg) From Baseline to Week 28	Baseline to Week 28	Change in body weight (kg) from baseline to Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16	Baseline to Week 16	Change in 2-hour postprandial glucose concentrations from baseline to Week 16.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Spokane, Washington, United States