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

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

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)

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