We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118963
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Aim:

The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.

Methodology:

Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Metformin Drug: Insulin BIAsp30 (Novolog 70/30) Drug: Repaglinide Drug: Placebo-Metformin Drug: Placebo-Repaglinide Phase 4

Detailed Description:
After four months run-in with repaglinide plus metformin combination-therapy, patients with HemoglobinA1c ≥6.5% will be randomized (baseline=0 month) to repaglinide 2 mg thrice-daily or metformin 1g twice-daily, both in combination with BIAsp30 (30% insulin-aspart; 70% protaminated insulin-aspart) (6U once-daily, pre-dinner) for 12 months.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents
Study Start Date : January 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 3
BIAsp30 plus Metformin plus Placebo-Repaglinide. Double-Masked and randomized. Duration: 12 months.
 Drug: Metformin
Tablets of 500 mg; 1000 mg two times daily.

Drug: Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.

Drug: Placebo-Repaglinide
Tablet corresponding to 1 mg; two tablets three times daily.
Active Comparator: 2
BIAsp30 plus Repaglinide plus Placebo-Metformin. Double-masked and randomized. Duration: 12 months.
 Drug: Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.

Drug: Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.

Drug: Placebo-Metformin
Tablets corresponding to 500 mg; two tablets two times daily.
1
Run-in period of four months duration with Repaglinide 6 mg daily plus Metformin 2000 mg daily. No masking of interventions.
 Drug: Metformin
Tablets of 500 mg; 1000 mg two times daily.

Drug: Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Glycemic control (HbA1c).

Secondary Outcome Measures :
  1. Hypoglycaemic events
  2. Home monitored plasma-glucose profiles
  3. Insulin-dose
  4. Non-glycemic cardiovascular risk factors: 24h blood-pressure measurement
  5. 24h urinary albumin excretion-rate.
  6. Fasting and postprandial 5-point-profiles of total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, free fatty acids, p-glucose, c-peptide and insulin after a standard test-meal
  7. Markers of endothelial dysfunction, inflammation and fibrinolysis including Small-dense-LDL, Lp(a) and Apo B100, von Willebrand-factor, ICAM, VCAM, selectin, endothelin, Amadori-protein, CRP, fibrinogen, IL-6, TNF-alfa, ADMA, PAI- and t-PA-activity

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-obese patients (BMI < 27 kg/m2)
  • Type 2 diabetes
  • Age 40 years or older
  • HbA1c = 6.5% or higher at baseline.

Exclusion Criteria:

  • No known contraindications for either of the study-drugs (known allergy to the study-drugs; heart-, liver- or kidney-failure)
  • Pregnancy
  • Other serious physical or mental illnesses with a life-shortening prognosis.
  • Drug or alcohol abuse.
  • Weight-loss of more than 5 kg during the last 6 month prior to enrollment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118963


Locations
Layout table for location information
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
Layout table for investigator information
Study Chair: Allan A Vaag, M.D. Chief Physician Steno Diabetes Center Copenhagen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00118963    
Other Study ID Numbers: Reform
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Insulin Aspart
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs