The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bethesda General Hospital, Hoogeveen
• Collaborators: Dupont Merck; LifeScan; Merck KGaA; Merck KGaA, Darmstadt, Germany; Merck Sharp & Dohme Corp.; Novo Nordisk A/S; Takeda
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

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