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

This study has been completed.

First Received: September 12, 2006 No Changes Posted

Sponsor:	Bethesda General Hospital, Hoogeveen
Collaborators:	ALTANA Pharma LifeScan Merck KGaA Dupont Merck Merck Novo Nordisk
Information provided by:	Bethesda General Hospital, Hoogeveen
ClinicalTrials.gov Identifier:	NCT00375388

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Metformin Metformin hydrochloride

U.S. FDA Resources

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, Drenthe
Bethesda General Hospital and Bethesda Diabetes Center
Hoogeveen, Drenthe, Netherlands, 7909 AA

Sponsors and Collaborators

Bethesda General Hospital, Hoogeveen

ALTANA Pharma

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:

Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2133-40.

Study ID Numbers:	MET/NL/97.01
Study First Received:	September 12, 2006
Last Updated:	September 12, 2006
ClinicalTrials.gov Identifier:	NCT00375388 History of Changes
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:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010