Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: exenatide (Drug); Insulin glargine (Drug); Metformin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Vice President, Research and Development, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
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 using metformin.
Clinical Details
Official title: A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Beta-cell Function After 52 Weeks of Therapy
Secondary outcome: Beta-cell Function 4 Weeks After Cessation of TherapyChange in First Phase C-peptide Release Change in Second Phase C-peptide Release Change in Glycosylated Hemoglobin (HbA1c) Change in Fasting Plasma Glucose Seven Point Self Monitored Blood Glucose (SMBG) Measurements Change in Body Weight M-value at Baseline, Week 52 and Week 56
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Research Site, Helsinki, Finland
Research Site, Amsterdam, Netherlands
Research Site, Goteborg, Sweden
Additional Information
Starting date: September 2004
Last updated: March 19, 2015
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