drugset / Trial / NCT00375388
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
Phase 3
Completed
400 enrolled
Bethesda General Hospital, Hoogeveen
Dupont Merck · collabLifeScan · collabMerck KGaA, Darmstadt, Germany · collabMerck Sharp & Dohme LLC · collabNovo Nordisk A/S · collabTakeda · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Timeline
- Start
- 1998-01
- Primary completion
- —
- Completion
- 2002-10
Publications
- Results Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2133-40. doi: 10.2337/diacare.25.12.2133.
- Stultiens JMG, Top WMC, Kimenai DM, Lehert P, Bekers O, Stehouwer CDA, Kooy A, Meex SJR. Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial. Cardiovasc Diabetol. 2022 Apr 4;21(1):49. doi: 10.1186/s12933-022-01482-z.
- Out M, Becker ML, van Schaik RH, Lehert P, Stehouwer CD, Kooy A. A gene variant near ATM affects the response to metformin and metformin plasma levels: a post hoc analysis of an RCT. Pharmacogenomics. 2018 Jun 1;19(8):715-726. doi: 10.2217/pgs-2018-0010. Epub 2018 May 23.
- Out M, Top WMC, Lehert P, Schalkwijk CA, Stehouwer CDA, Kooy A. Long-term treatment with metformin in type 2 diabetes and vitamin D levels: A post-hoc analysis of a randomized placebo-controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1951-1956. doi: 10.1111/dom.13327. Epub 2018 May 14.
- Out M, Kooy A, Lehert P, Schalkwijk CA, Stehouwer CDA. Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: Post hoc analysis of a randomized controlled 4.3year trial. J Diabetes Complications. 2018 Feb;32(2):171-178. doi: 10.1016/j.jdiacomp.2017.11.001. Epub 2017 Nov 8.
- Out M, Miedema I, Jager-Wittenaar H, van der Schans C, Krijnen W, Lehert P, Stehouwer C, Kooy A. Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. Diabetes Obes Metab. 2018 Jan;20(1):219-223. doi: 10.1111/dom.13054. Epub 2017 Sep 14.
- de Jager J, Kooy A, Lehert P, Wulffele MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181.
- Kooy A, de Jager J, Lehert P, Bets D, Wulffele MG, Donker AJ, Stehouwer CD. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009 Mar 23;169(6):616-25. doi: 10.1001/archinternmed.2009.20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 850 mg | — |
| Background | Insulin | Protein / enzyme biologic | — | — |