Status:

COMPLETED

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

30-75 years

Phase:

PHASE3

Brief Summary

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus usi...

Eligibility Criteria

Inclusion

  • Diagnosis of type 2 diabetes, but otherwise healthy
  • HbA1c between 6.6% and 9.5%, inclusive.
  • Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
  • Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion

  • Patients previously in a study using exenatide.
  • Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
  • Treated with insulin within 3 months of screening.

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT00097500

Start Date

September 1 2004

End Date

December 1 2009

Last Update

April 7 2015

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Research Site

Helsinki, Finland

2

Research Site

Amsterdam, Netherlands

3

Research Site

Gothenburg, Sweden