Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide/insulin glargine; Drug: insulin glargine/exenatide

• Registration Number: NCT00099619
• Lead Sponsor: AstraZeneca

Brief Summary

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
• HbA1c between 7.1% and 11.0%, inclusive.
• Insulin therapy should be the next appropriate step of diabetes treatment.
• Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main

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Exclusion Criteria

• Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
• Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
exenatide/insulin glargine	exenatide/insulin glargine	Arm that first receives exenatide, then crosses over to insulin glargine
Insulin glargine/exenatide	insulin glargine/exenatide	Arm that first receives insulin glargine, then crosses over to exenatide

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.	Baseline, Week 16, Week 32	Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.

Secondary Outcome Measures

Name	Time	Method
Change in patient-reported outcomes from Baseline to the end of each 16-week period	Baseline, Week 16, Week 32	Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires \[Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument\] from Baseline to the end of each 16-week exenatide or insulin glargine period

Trial Locations

Locations (1)

Research Site; 🇵🇱 Lublin, Poland