- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00097500
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
March 19, 2015 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland
- Research Site
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Amsterdam, Netherlands
- Research Site
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Goteborg, Sweden
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Exenatide Arm
Exenatide and Metformin
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subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
Other Names:
Patients usual dosage
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Active Comparator: Insulin Glargine Arm
Insulin Glargine and Metformin
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Patients usual dosage
subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Beta-cell Function After 52 Weeks of Therapy
Time Frame: Baseline (week -2) and 52 weeks
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Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).
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Baseline (week -2) and 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Beta-cell Function 4 Weeks After Cessation of Therapy
Time Frame: Baseline (week -2) and 56 weeks
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Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).
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Baseline (week -2) and 56 weeks
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Change in First Phase C-peptide Release
Time Frame: baseline (week -2), 52 weeks, and 56 weeks
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Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]).
C-peptide is measured as a surrogate marker of insulin secretion.
First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.
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baseline (week -2), 52 weeks, and 56 weeks
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Change in Second Phase C-peptide Release
Time Frame: baseline (-2 weeks), 52 weeks, and 56 weeks
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Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]).
C-peptide is measured as a surrogate marker of insulin secretion.
Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.
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baseline (-2 weeks), 52 weeks, and 56 weeks
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Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: Week 0 and week 52
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Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).
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Week 0 and week 52
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Change in Fasting Plasma Glucose
Time Frame: 0 weeks and 52 weeks
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Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).
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0 weeks and 52 weeks
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Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Time Frame: 0 weeks and 52 weeks
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SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).
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0 weeks and 52 weeks
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Change in Body Weight
Time Frame: 0 weeks and 52 weeks
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Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).
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0 weeks and 52 weeks
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M-value at Baseline, Week 52 and Week 56
Time Frame: baseline (week -2), 52 weeks, and 56 weeks
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M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period).
Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56.
Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.
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baseline (week -2), 52 weeks, and 56 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Vice President, Research and Development, MD, Amylin Pharmaceuticals, LLC.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 24, 2004
First Submitted That Met QC Criteria
November 24, 2004
First Posted (Estimate)
November 25, 2004
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2993-114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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