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CompletedNCT00118950Updated Dec 8, 2008

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

A Phase 4 interventional study of Metformin and Repaglinide in Diabetes Mellitus, Type 2, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2008-12-08.

Sponsored by Steno Diabetes Center Copenhagen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants

Study arms

  • Active comparator
    4

    Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.

    Drug: Metformin · Drug: Placebo-Repaglinide.

  • Active comparator
    2

    Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.

    Drug: Repaglinide · Drug: Placebo-Metformin.

  • Other
    1

    Run-in period: Treatment: Diet-only. Duration: One month.

    Other: Diet-only.

  • Other
    3

    Wash-out period: Treatment: Diet-only: Duration: One month.

    Other: Diet-only.

Interventions

  • DrugMetformin

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

  • DrugRepaglinide

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

  • DrugPlacebo-Metformin.

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

  • DrugPlacebo-Repaglinide.

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

  • OtherDiet-only.

    Diet-only treatment. Duration: One month.

06

What researchers measure

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).

07

Study locations

1 site
  • Steno Diabetes Center
    Gentofte, 2820, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00118950
Lead sponsor
Steno Diabetes Center Copenhagen
First posted
Jul 12, 2005
Start date
Mar 2001
Completion
Mar 2003
Last update
Dec 8, 2008

Study contacts

Allan A Vaag, M. D., Chief Physician
study chair · Steno Diabetes Center Copenhagen
Soeren S Lund, M. D.
principal investigator · Steno Diabetes Center Copenhagen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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