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

Overview

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.

Full Title of Study: “Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2005

Interventions

  • Drug: exenatide/insulin glargine
    • Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
  • Drug: insulin glargine/exenatide
    • Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks

Arms, Groups and Cohorts

  • Experimental: exenatide/insulin glargine
    • Arm that first receives exenatide, then crosses over to insulin glargine
  • Experimental: Insulin glargine/exenatide
    • Arm that first receives insulin glargine, then crosses over to exenatide

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 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 Measures

  • Change in patient-reported outcomes from Baseline to the end of each 16-week period
    • Time Frame: 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

Participating in This Clinical Trial

Main 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 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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Malone, MD, Study Director, Eli Lilly and Company

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.