search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Metformin
Repaglinide
Placebo-Metformin.
Placebo-Repaglinide.
Diet-only.
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Steno Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Other

Other

Arm Label

4

2

1

3

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

HaemoglobinA1c

Secondary Outcome Measures

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).

Full Information

First Posted
July 1, 2005
Last Updated
December 5, 2008
Sponsor
Steno Diabetes Center Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT00118950
Brief Title
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Steno Diabetes Center Copenhagen

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Arm Title
4
Arm Type
Active Comparator
Arm Description
Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months.
Arm Title
1
Arm Type
Other
Arm Description
Run-in period: Treatment: Diet-only. Duration: One month.
Arm Title
3
Arm Type
Other
Arm Description
Wash-out period: Treatment: Diet-only: Duration: One month.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
Intervention Type
Drug
Intervention Name(s)
Repaglinide
Intervention Description
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Intervention Type
Drug
Intervention Name(s)
Placebo-Metformin.
Intervention Description
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
Intervention Type
Drug
Intervention Name(s)
Placebo-Repaglinide.
Intervention Description
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
Intervention Type
Other
Intervention Name(s)
Diet-only.
Intervention Description
Diet-only treatment. Duration: One month.
Primary Outcome Measure Information:
Title
HaemoglobinA1c
Secondary Outcome Measure Information:
Title
Home-monitored 7-point plasma-glucose profiles
Title
Body-weight
Title
Waist- and hip-circumference
Title
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.).
Title
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).
Title
Albuminuria and 24-hour blood-pressure measurements.
Title
Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.
Title
DNA for genotyping.
Title
Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan A Vaag, M. D., Chief Physician
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Soeren S Lund, M. D.
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs