Status:
COMPLETED
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
Lead Sponsor:
Bethesda General Hospital, Hoogeveen
Collaborating Sponsors:
Takeda
LifeScan
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief 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 wit...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
End Date :
October 1 2002
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00375388
Start Date
January 1 1998
End Date
October 1 2002
Last Update
September 13 2006
Active Locations (1)
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1
Bethesda General Hospital and Bethesda Diabetes Center
Hoogeveen, Drenthe, Netherlands, 7909 AA