the home trial: hyperinsulinaemia: the outcome of its metabolic effects, a randomized controlled trial

Conditions: Type 2 Diabetes Mellitus

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.

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. phase: phase iii study type: interventional overall status: no longer recruiting (all patients have finished the study) study start date 02 january 1998 study completion date october 2002 study design: study purpose: treatment allocation: 1 randomized 0 non randomized masking: double blind control: placebo assignment: parallel endpoints: safety / efficacy primary outcome: • to investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight). secondary outcome: * to investigate the occurrence of macro- and microvascular complications. * to investigate the quality of life and to perform a socio-economic evaluation. conditions: type 2 diabetes mellitus requiring insulin therapy. keywords: type 2 diabetes mellitus; metformin; randomized; double-blind; placebo-controlled; diabetes regulation interventions: metformin (850 mg) or placebo 1-3 times daily. insulin: 4 times daily or 'mixtures' of 30% rapidly and 70% slowly acting insulin, 2 times daily. eligibility criteria (only add main ones) inclusion criteria: * patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception) * type 2 dm requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated hb \> 7.5%) and need for exogenous insulin. (no concomitant use of oral antidiabetic agents) * being ambulatory * age: 30 to 80 years * proven absence of islet antibodies, if qi \< 28 kg/m2 * insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting) * standard dietary prescription by the dietician * absence of keto-acidosis * informed consent exclusion criteria: * congestive heart failure, nyha-classes iii or iv * cardiac failure and/or myocardial infarction in the last four months before enrolment * other severe organic / systemic disease * metformin-induced lactic-acidosis * intolerance to metformin hydrochloride * renal disease or renal dysfunction * hypoxic states * severe hepatic dysfunction * excessive alcohol intake, acute or chronic * acute or chronic metabolic acidosis gender: both age: 30 - 80 years target number of subjects: 400 (200 metformin, 200 placebo) central contact: name: adriaan kooy , internist - diabetologist degree: md, phd phone: 0528-286222 extension: 624 mail: kooy.a@bethesda.nl study official/ investigators name: adriaan kooy degree: md, phd officials role: study principal investigator organizational affiliation: bethesda hospital hoogeveen dr. g.h. amshoffweg 1 7909 aa hoogeveen the netherlands locations: facility: bethesda hospital hoogeveen city: hoogeveen state/province: drenthe country: the netherlands recruitment status: no longer recruiting (all patients finished) facility: diaconesses' hospital meppel city: meppel state/province: drenthe country: the netherlands recruitment status: no longer recruiting (all patients finished) facility: hospital coevorden - hardenberg city: coevorden state/province: drenthe country: the netherlands recruitment status: no longer recruiting (all patients finished)

Eligibility criteria:
inclusion criteria: * patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception) * type 2 dm requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated hb \> 7.5%) and need for exogenous insulin. (no concomitant use of oral antidiabetic agents) * being ambulatory * age: 30 to 80 years * proven absence of islet antibodies, if qi \< 28 kg/m2 * insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting) * standard dietary prescription by the dietician * absence of keto-acidosis * informed consent exclusion criteria: * congestive heart failure, nyha-classes iii or iv * cardiac failure and/or myocardial infarction in the last four months before enrolment * other severe organic / systemic disease * metformin-induced lactic-acidosis * intolerance to metformin hydrochloride * renal disease or renal dysfunction * hypoxic states * severe hepatic dysfunction * excessive alcohol intake, acute or chronic * acute or chronic metabolic acidosis

Keywords: type 2 diabetes mellitus metformin on top of insulin therapy randomized placebo-controlled trial diabetes regulation daily dose of insulin body weight patients with type 2 diabetes intensive insulin therapy age: 30-80 years body mass index lipids blood pressure endothelial function low grade inflammation fibrinolysis microvascular complications macrovascular complications