Status:
COMPLETED
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients...
Eligibility Criteria
Inclusion
- Type-2 diabetes, defined as:
- Age at onset of diabetes ≥ 40 years
- Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
- No history of ketonuria or ketoacidosis.
- BMI ≤ 27 kg/m2.
- Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
- HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.
- Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.
Exclusion
- Type-1 diabetes
- Insulin-treated type-2 diabetes
- Secondary diabetes, heart-failure
- Serum-creatinine above the upper limit
- Serum-ASAT elevated more than 3 fold above the upper limit
- Factor II-VII-X decreased below 0.7
- Ongoing coexisting illnesses with a life-shortening prognosis
- Mental retardation or reduced intellectual behaviour
- Pregnancy
- History of drug-abuse or HbA1c\>10.5% at two separate visits with at least one month interval during treatment-periods.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00118950
Start Date
March 1 2001
End Date
March 1 2003
Last Update
December 8 2008
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820