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)
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.