The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00375388
- Lead Sponsor
- Bethesda General Hospital, Hoogeveen
- Brief 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
- Secondary Outcome Measures
Name Time Method To investigate the occurrence and progression of macro- and microvascular complications. To investigate the quality of life. To perform a socio-economic evaluation.
Trial Locations
- Locations (1)
Bethesda General Hospital and Bethesda Diabetes Center
🇳🇱Hoogeveen, Drenthe, Netherlands