Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
NCT ID: NCT00118950
Last Updated: 2008-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2001-03-31
2003-03-31
Brief Summary
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Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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4
Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
Metformin
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
Placebo-Repaglinide.
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
2
Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.
Repaglinide
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Placebo-Metformin.
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
1
Run-in period: Treatment: Diet-only. Duration: One month.
Diet-only.
Diet-only treatment. Duration: One month.
3
Wash-out period: Treatment: Diet-only: Duration: One month.
Diet-only.
Diet-only treatment. Duration: One month.
Interventions
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Metformin
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
Repaglinide
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Placebo-Metformin.
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
Placebo-Repaglinide.
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
Diet-only.
Diet-only treatment. Duration: One month.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
40 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Principal Investigators
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Allan A Vaag, M. D., Chief Physician
Role: STUDY_CHAIR
Steno Diabetes Center Copenhagen
Soeren S Lund, M. D.
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center
Gentofte Municipality, , Denmark
Countries
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Other Identifiers
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ReMet
Identifier Type: -
Identifier Source: org_study_id