drugset / Trial / NCT00184600
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
Timeline
- Start
- 2004-11
- Primary completion
- 2009-08
- Completion
- 2009-08
Publications
- Results Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22.
- Results Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007 Oct 25;357(17):1716-30. doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.
- Results Jenkins N, Hallowell N, Farmer AJ, Holman RR, Lawton J. Participants' experiences of intensifying insulin therapy during the Treating to Target in Type 2 Diabetes (4-T) trial: qualitative interview study. Diabet Med. 2011 May;28(5):543-8. doi: 10.1111/j.1464-5491.2010.03200.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | biphasic insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |