The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

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.
    

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)
    

Intervention name(s): Metformin on top of intensive insulin therapy
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
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