MedTrace Logo

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

NCT00375388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2006-09-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin on top of intensive insulin therapy

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • LifeScan

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Dupont Merck

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Bethesda General Hospital, Hoogeveen

    lead OTHER

Principal Investigators

  • Adriaan Kooy, MD, PhD · Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)

  • Coen Stehouwer, MD, PhD · University Hospital of Maastricht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Completion
2002-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375388 on ClinicalTrials.gov