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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00375388
First Posted: September 13, 2006
Last Update Posted: September 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Takeda
LifeScan
Merck KGaA
Dupont Merck
Merck Sharp & Dohme Corp.
Novo Nordisk A/S
Information provided by:
Bethesda General Hospital, Hoogeveen
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375388


Locations
Netherlands
Bethesda General Hospital and Bethesda Diabetes Center
Hoogeveen, Drenthe, Netherlands, 7909 AA
Sponsors and Collaborators
Bethesda General Hospital, Hoogeveen
Takeda
LifeScan
Merck KGaA
Dupont Merck
Merck Sharp & Dohme Corp.
Novo Nordisk A/S
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:
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
First Submitted: September 12, 2006
First Posted: September 13, 2006
Last Update Posted: September 13, 2006
Last Verified: September 2006

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, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs