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

September 12, 2006
September 12, 2006
January 1998
Not Provided
To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Same as current
No Changes Posted
  • To investigate the occurrence and progression of macro- and microvascular complications.
  • To investigate the quality of life.
  • To perform a socio-economic evaluation.
Same as current
Not Provided
Not Provided
 
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
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

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.

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)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Metformin on top of intensive insulin therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2002
Not Provided

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00375388
MET/NL/97.01
Not Provided
Not Provided
Bethesda General Hospital, Hoogeveen
  • Takeda
  • LifeScan
  • Merck KGaA
  • Dupont Merck
  • Merck Sharp & Dohme Corp.
  • Novo Nordisk A/S
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
Bethesda General Hospital, Hoogeveen
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP