Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
Summary
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-07
- Completion
- 2011-01
Outcome
Mixed primary results
paper EQW was noninferior to MET but not PIO and superior to SITA with regard to HbA(1c) reduction at 26 weeks. PMID 22210563 ↗
registry analysis (non-inferiority or equivalence test); Exenatide Once Weekly vs Metformin; p = 0.620; Least Squares Mean Difference -0.05 (98.3% CI -0.26 to 0.17) NCT00676338 ↗
registry analysis (non-inferiority or equivalence test); Exenatide Once Weekly vs Pioglitazone; p = 0.328; Least Squares Mean Difference 0.10 (98.3% CI -0.15 to 0.35) NCT00676338 ↗
registry analysis (non-inferiority or equivalence test); Exenatide Once Weekly vs Sitagliptin; p <.001; Least Squares Mean Difference -0.37 (98.3% CI -0.62 to -0.13) NCT00676338 ↗
registry analysis (superiority or other test); Exenatide Once Weekly vs Metformin; p = 0.151; Fisher Exact; note: No multiple adjustment were done. NCT00676338 ↗
registry analysis (superiority or other test); Exenatide Once Weekly vs Pioglitazone; p = 0.913; Fisher Exact; note: No multiple adjustment were done. NCT00676338 ↗
registry analysis (superiority or other test); Exenatide Once Weekly vs Sitagliptin; p <.001; Fisher Exact; note: No multiple adjustment were done. NCT00676338 ↗
Publications
- Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
- Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
- Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
- Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
- Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 2 mg | Subcutaneous |
| Comparator | Metformin | Small molecule | 1000 mg | Oral |
| Comparator | Metformin | Small molecule | 2500 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 30 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 45 mg | Oral |
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |