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

This study has been completed.
Sponsor:
Collaborators:
Takeda
LifeScan
Merck KGaA
Dupont Merck
Merck Sharp & Dohme Corp.
Novo Nordisk A/S
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
  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
  Hide Detailed Description

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)

  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
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:
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014