Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT00097500
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
2004-09-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exenatide Arm
Exenatide and Metformin
exenatide
subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
Metformin
Patients usual dosage
Insulin Glargine Arm
Insulin Glargine and Metformin
Insulin glargine
subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
Metformin
Patients usual dosage
Interventions
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exenatide
subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
Insulin glargine
subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
Metformin
Patients usual dosage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Vice President, Research and Development, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Helsinki, , Finland
Research Site
Amsterdam, , Netherlands
Research Site
Gothenburg, , Sweden
Countries
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References
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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.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
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.
Other Identifiers
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2993-114
Identifier Type: -
Identifier Source: org_study_id
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