drugset / Trial / NCT00366301
The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes
RandomizedFactorialOpen-labelTreatment
Summary
The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.
Timeline
- Start
- 2006-08
- Primary completion
- 2009-04
- Completion
- 2009-04
Outcome
Outcome not reported
Stopped (Enrollment): “Interim analyses demonstrated futility. Thus, recruitment curtailed 10/08.”
Publications
- Srivastava PK, Pradhan AD, Cook NR, Ridker PM, Everett BM. Randomized Trial of the Effects of Insulin and Metformin on Myocardial Injury and Stress in Diabetes Mellitus: A Post Hoc Exploratory Analysis. J Am Heart Assoc. 2017 Dec 23;6(12):e007268. doi: 10.1161/JAHA.117.007268.
- Pradhan AD, Everett BM, Cook NR, Rifai N, Ridker PM. Effects of initiating insulin and metformin on glycemic control and inflammatory biomarkers among patients with type 2 diabetes: the LANCET randomized trial. JAMA. 2009 Sep 16;302(11):1186-94. doi: 10.1001/jama.2009.1347.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 2 g | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |