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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375388
• Other study ID #: MET/NL/97.01
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2006
• Last updated: September 12, 2006
• Start date: January 1998
• Est. completion date: October 2002

Study information

• Verified date: September 2006
• Source: Bethesda General Hospital, Hoogeveen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin on top of intensive insulin therapy

Locations

Country	Name	City	State
Netherlands	Bethesda General Hospital and Bethesda Diabetes Center	Hoogeveen	Drenthe

Sponsors (7)

Lead Sponsor	Collaborator
Bethesda General Hospital, Hoogeveen	Dupont Merck, LifeScan, Merck KGaA, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Takeda

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Wulffelé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Secondary	To investigate the occurrence and progression of macro- and microvascular complications.
Secondary	To investigate the quality of life.
Secondary	To perform a socio-economic evaluation.