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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Metformin on top of intensive insulin therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin on top of intensive insulin therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the occurrence and progression of macro- and microvascular complications. |  |  | 
| To investigate the quality of life. |  |  | 
| To perform a socio-economic evaluation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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