The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
|Type 2 Diabetes Mellitus||Drug: Metformin on top of intensive insulin therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
- To investigate the occurrence and progression of macro- and microvascular complications.
- To investigate the quality of life.
- To perform a socio-economic evaluation.
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||October 2002|
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 Purpose: Treatment Allocation: 1 randomized 0 non randomized Masking: Double blind Control: Placebo Assignment: Parallel Endpoints: Safety / Efficacy
• To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
- To investigate the occurrence of macro- and microvascular complications.
- To investigate the quality of life and to perform a socio-economic evaluation.
Type 2 diabetes mellitus requiring insulin therapy.
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)
- 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
- 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
Age: 30 - 80 years
Target Number of Subjects: 400 (200 metformin, 200 placebo)
Name: Adriaan Kooy , internist – diabetologist Degree: MD, PhD Phone: 0528-286222 Extension: 624 Mail: firstname.lastname@example.org
Study Official/ Investigators Name: Adriaan Kooy Degree: MD, PhD Officials Role: Study Principal Investigator
Bethesda Hospital Hoogeveen Dr. G.H. Amshoffweg 1 7909 AA Hoogeveen The Netherlands
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375388
|Bethesda General Hospital and Bethesda Diabetes Center|
|Hoogeveen, Drenthe, Netherlands, 7909 AA|
|Principal Investigator:||Adriaan Kooy, MD, PhD||Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)|
|Study Director:||Coen Stehouwer, MD, PhD||University Hospital of Maastricht, The Netherlands|