Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: exenatide

• Registration Number: NCT00324363
• Lead Sponsor: AstraZeneca

Brief Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

• Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
• HbA1c between 7.1% and 11.0%, inclusive.
• Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.

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Exclusion Criteria

• Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
• Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
• Have characteristics contraindicating metformin or sulfonylurea use.
• Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
• Have used drugs for weight loss within 1 month of screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo in volume equal to exenatide
Exenatide	exenatide	Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.	16 weeks

Secondary Outcome Measures

Name	Time	Method
To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements	16 weeks

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taipei, Taiwan