Clinical trial NCT00097500: Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
exendin-4
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2004-11-25
Enrollment: 69
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 using metformin.


Eligibility 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.

Primary outcomes:
measure: Beta-cell Function After 52 Weeks of Therapy
timeFrame: Baseline (week -2) and 52 weeks
Secondary outcomes:
measure: Beta-cell Function 4 Weeks After Cessation of Therapy
timeFrame: Baseline (week -2) and 56 weeks
measure: Change in First Phase C-peptide Release
timeFrame: baseline (week -2), 52 weeks, and 56 weeks
measure: Change in Second Phase C-peptide Release
timeFrame: baseline (-2 weeks), 52 weeks, and 56 weeks
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: Week 0 and week 52
measure: Change in Fasting Plasma Glucose
timeFrame: 0 weeks and 52 weeks
measure: Seven Point Self Monitored Blood Glucose (SMBG) Measurements
timeFrame: 0 weeks and 52 weeks
measure: Change in Body Weight
timeFrame: 0 weeks and 52 weeks
measure: M-value at Baseline, Week 52 and Week 56
timeFrame: baseline (week -2), 52 weeks, and 56 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Vice President, Research and Development, MD
role: STUDY_DIRECTOR
References:
citation: Bunck MC, Diamant M, Corner A, Eliasson B, Malloy JL, Shaginian RM, Deng W, Kendall DM, Taskinen MR, Smith U, Yki-Jarvinen H, Heine RJ. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009 May;32(5):762-8. doi: 10.2337/dc08-1797. Epub 2009 Feb 5.
citation: Muskiet MHA, Bunck MC, Heine RJ, Corner A, Yki-Jarvinen H, Eliasson B, Joles JA, Diamant M, Tonneijck L, van Raalte DH. Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. Diabetes Res Clin Pract. 2019 Jul;153:14-22. doi: 10.1016/j.diabres.2019.05.001. Epub 2019 May 9.
citation: Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Jarvinen H, Diamant M. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7. doi: 10.2337/dc11-0291.
citation: Bunck MC, Corner A, Eliasson B, Heine RJ, Shaginian RM, Wu Y, Yan P, Smith U, Yki-Jarvinen H, Diamant M, Taskinen MR. One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Atherosclerosis. 2010 Sep;212(1):223-9. doi: 10.1016/j.atherosclerosis.2010.04.024. Epub 2010 Apr 29.