Primary outcome
What NCT00097500 measured first
| Exenatide Armn=30 | Insulin Glargine Armn=30 |
|---|---|
| 2.89(0.27) | 1.15(0.11) |
Phase 3 · Exenatide
NCT00097500 trial results
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
Beta-cell Function After 52 Weeks of Therapy (ratio), Baseline (week -2) and 52 weeks. Exenatide Arm: 2.89; Insulin Glargine Arm: 1.15.
- Participants
- 69
- Status
- completed
- Completed
- 2009-12
- Sponsor
- AstraZeneca
As posted on ClinicalTrials.gov (NCT00097500), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00097500
Percent of participants affected, Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.. The most common events the registry lists.
| Event | Exenatide Arm | Insulin Glargine Arm |
|---|---|---|
| Any serious event | 8.3% | 3% |
| Nausea | 50% | 0% |
| Hypoglycemia | 16.7% | 30.3% |
| Influenza | 13.9% | 27.3% |
| Dyspepsia | 13.9% | 6.1% |
| Anemia | 2.8% | 12.1% |
| Gastroenteritis | 2.8% | 12.1% |
| Arthralgia | 5.6% | 12.1% |
| Abdominal Distension | 11.1% | 0% |
| Vomiting | 11.1% | 0% |
| Hyperlipidemia | 0% | 9.1% |
| Diarrhea | 8.3% | 3% |
| Flatulence | 8.3% | 0% |
| Injection Site Rash | 8.3% | 0% |
| Urinary Tract Infection | 8.3% | 6.1% |
| Decreased Appetite | 8.3% | 0% |
| Edema Peripheral | 0% | 6.1% |
| Tooth Infection | 0% | 6.1% |
| Headache | 2.8% | 6.1% |
| Hypertension | 0% | 6.1% |
| Laryngitis | 5.6% | 3% |
| Proteinuria | 5.6% | 0% |
Secondary outcomes
What else it measured
| Exenatide Armn=30 | Insulin Glargine Armn=30 |
|---|---|
| 1.02(0.06) | 1.08(0.07) |
| Measure | Exenatide Armn=29 | Insulin Glargine Armn=30 |
|---|---|---|
| 52 weeks | 1.72(0.11) | 1.13(0.07) |
| 56 weeks | 0.95(0.05) | 1.06(0.06) |
| Measure | Exenatide Armn=30 | Insulin Glargine Armn=30 |
|---|---|---|
| 52 weeks | 2.88(0.18) | 1.01(0.07) |
| 56 weeks | 1.00(0.05) | 1.08(0.06) |
| Exenatide Armn=36 | Insulin Glargine Armn=33 |
|---|---|
| -0.97(0.14) | -0.87(0.15) |
| Exenatide Armn=36 | Insulin Glargine Armn=33 |
|---|---|
| -1.53(0.25) | -3.10(0.27) |
| Measure | Exenatide Armn=36 | Insulin Glargine Armn=33 |
|---|---|---|
| Pre-breakfast measurement (week 0) | 8.92(1.80) | 8.38(1.91) |
| Pre-breakfast measurement (week 52) | 7.27(1.63) | 5.63(0.85) |
| 2-hour post-breakfast measurement (week 0) | 11.00(2.58) | 11.17(3.30) |
| 2-hour post-breakfast measurement (week 52) | 6.98(2.42) | 7.53(2.16) |
| Pre-lunch measurement (week 0) | 8.14(2.25) | 8.54(2.51) |
| Pre-lunch measurement (week 52) | 6.52(1.52) | 6.24(1.66) |
| 2-hour post-lunch measurement (week 0) | 9.90(2.54) | 10.52(2.96) |
| 2-hour post-lunch measurement (week 52) | 7.97(2.01) | 8.15(1.77) |
| Pre-dinner measurement (week 0) | 8.38(2.40) | 8.07(2.48) |
| Pre-dinner measurement (week 52) | 7.53(2.63) | 6.98(2.04) |
| 2-hour post-dinner measurement (week 0) | 10.42(2.42) | 10.26(2.82) |
| 2-hour post-dinner measurement (week 52) | 6.98(2.25) | 8.81(2.03) |
| Exenatide Armn=36 | Insulin Glargine Armn=33 |
|---|---|
| -3.80(0.87) | 0.75(0.95) |
| Measure | Exenatide Armn=30 | Insulin Glargine Armn=30 |
|---|---|---|
| baseline (week -2) | 2.24(0.39) | 2.79(0.26) |
| week 52 | 3.18(0.42) | 3.85(0.32) |
| week 56 | 3.19(0.44) | 2.81(0.29) |
The trial
How NCT00097500 was run
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.
- Exenatide Arm: Exenatide and Metformin
- Insulin Glargine Arm: Insulin Glargine and Metformin
Who could join the trial
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.
Published papers
Papers from NCT00097500
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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