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Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet

This study has been completed.
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00118950
First received: July 1, 2005
Last updated: December 5, 2008
Last verified: December 2008

July 1, 2005
December 5, 2008
March 2001
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HaemoglobinA1c
Not Provided
Complete list of historical versions of study NCT00118950 on ClinicalTrials.gov Archive Site
  • Home-monitored 7-point plasma-glucose profiles
  • Body-weight
  • Waist- and hip-circumference
  • Fasting and postprandial (after a standard test-meal) measures of plasma-glucose, insulin, c-peptide, free fatty acids, lipoproteins, triglycerides and other markers related to lipid-metabolism (e.g. apo-lipoproteins, lipoprotein particle size etc.).
  • Biomarkers related to inflammation, endothelial dysfunction and fibrinolysis (e.g. hs-CRP, TNF-alpha, IL-6, ICAM, VCAM, E-selectin, vWF, PAI-1 and t-PA, adiponectin, ADMA, AGE-peptides).
  • Albuminuria and 24-hour blood-pressure measurements.
  • Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.
  • DNA for genotyping.
  • Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).
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Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
Effect of Metformin Versus Repaglinide Treatment on Glycemic Control and Non-Glycaemic Cardiovascular Risk Factors in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet

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 insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM.

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Metformin
    Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
  • Drug: Repaglinide
    Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
  • Drug: Placebo-Metformin.
    Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
  • Drug: Placebo-Repaglinide.
    Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
  • Other: Diet-only.
    Diet-only treatment. Duration: One month.
  • Active Comparator: 4
    Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
    Interventions:
    • Drug: Metformin
    • Drug: Placebo-Repaglinide.
  • Active Comparator: 2
    Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.
    Interventions:
    • Drug: Repaglinide
    • Drug: Placebo-Metformin.
  • 1
    Run-in period: Treatment: Diet-only. Duration: One month.
    Intervention: Other: Diet-only.
  • 3
    Wash-out period: Treatment: Diet-only: Duration: One month.
    Intervention: Other: Diet-only.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2003
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Inclusion Criteria:

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 Criteria:

  • 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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00118950
ReMet
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Steno Diabetes Center
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Study Chair: Allan A Vaag, M. D., Chief Physician Steno Diabetes Center
Principal Investigator: Soeren S Lund, M. D. Steno Diabetes Center
Steno Diabetes Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP