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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 Therapy

Change 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

Page last updated: August 23, 2015

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