The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
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.
Type 2 Diabetes Mellitus
Drug: Metformin on top of intensive insulin therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial|
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
- To investigate the occurrence and progression of macro- and microvascular complications.
- To investigate the quality of life.
- To perform a socio-economic evaluation.
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||October 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375388
|Bethesda General Hospital and Bethesda Diabetes Center|
|Hoogeveen, Drenthe, Netherlands, 7909 AA|
|Principal Investigator:||Adriaan Kooy, MD, PhD||Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)|
|Study Director:||Coen Stehouwer, MD, PhD||University Hospital of Maastricht, The Netherlands|