The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
This study has been completed.
Sponsor:
Bethesda General Hospital, Hoogeveen
Collaborators:
Takeda Global Research & Development Center, Inc.
LifeScan
Merck KGaA
Dupont Merck
Merck
Novo Nordisk
Information provided by:
Bethesda General Hospital, Hoogeveen
ClinicalTrials.gov Identifier:
NCT00375388
First received: September 12, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Metformin on top of intensive insulin therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Bethesda General Hospital, Hoogeveen:
Primary Outcome Measures:
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Secondary Outcome Measures:
- To investigate the occurrence and progression of macro- and microvascular complications.
- To investigate the quality of life.
- To perform a socio-economic evaluation.
| Estimated Enrollment: | 400 |
| Study Start Date: | January 1998 |
| Estimated Study Completion Date: | October 2002 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375388
Locations
| Netherlands | |
| Bethesda General Hospital and Bethesda Diabetes Center | |
| Hoogeveen, Drenthe, Netherlands, 7909 AA | |
Sponsors and Collaborators
Bethesda General Hospital, Hoogeveen
Takeda Global Research & Development Center, Inc.
LifeScan
Merck KGaA
Dupont Merck
Merck
Novo Nordisk
Investigators
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00375388 History of Changes |
| Other Study ID Numbers: | MET/NL/97.01 |
| Study First Received: | September 12, 2006 |
| Last Updated: | September 12, 2006 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Bethesda General Hospital, Hoogeveen:
|
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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013