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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Detailed Description

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)

Interventions

  • Drug: Metformin on top of intensive insulin therapy

Clinical Trial Outcome Measures

Primary Measures

  • To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).

Secondary Measures

  • To investigate the occurrence and progression of macro- and microvascular complications.
  • To investigate the quality of life.
  • To perform a socio-economic evaluation.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bethesda General Hospital, Hoogeveen
  • Collaborator
    • Takeda
  • Overall Official(s)
    • Adriaan Kooy, MD, PhD, Principal Investigator, Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)
    • Coen Stehouwer, MD, PhD, Study Director, University Hospital of Maastricht, The Netherlands

Citations Reporting on 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.

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