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Completed

NCT Number: NCT00118950

Effect of Metformin Versus Repaglinide Treatment 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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.

repaglinide

Drug

Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.

Placebo-Metformin.

Drug

Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.

Placebo-Repaglinide.

Drug

Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.

Diet-only.

Other

Diet-only treatment. Duration: One month.

Primary outcomes

  1. HaemoglobinA1c

Secondary outcomes

  1. Home-monitored 7-point plasma-glucose profiles

  2. Body-weight

  3. Waist- and hip-circumference

  4. 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.).

  5. 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).

  6. Albuminuria and 24-hour blood-pressure measurements.

  7. Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.

  8. DNA for genotyping.

  9. Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Jul 12, 2005
Registry last updated
Dec 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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