Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

February 17, 2017 updated by: Novo Nordisk A/S

Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08020
        • Novo Nordisk Investigational Site
      • Benamargosa, Spain, 29718
        • Novo Nordisk Investigational Site
      • Burlada, Spain, 31600
        • Novo Nordisk Investigational Site
      • Camas, Spain, 41900
        • Novo Nordisk Investigational Site
      • Fuenlabrada, Spain, 28942
        • Novo Nordisk Investigational Site
      • Gijón, Spain, 33212
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Lugo, Spain, 27004
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28021
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28030
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28035
        • Novo Nordisk Investigational Site
      • Portugalete, Spain, 48920
        • Novo Nordisk Investigational Site
      • San Adria del Besos, Spain, 08930
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39009
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39011
        • Novo Nordisk Investigational Site
      • Tegueste, Spain, 38280
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46021
        • Novo Nordisk Investigational Site
      • Zaragoza, Spain, 50007
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Treated by diet for at least 3 months
  • Never treated with hypoglycaemic drugs
  • HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria:

  • Very symptomatic diabetes
  • Advanced vascular complications
  • Manifest renal failure
  • Manifest hepatic disease
  • Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Met
Drug: metformin
Adminstered orally during the three main meals for 24 weeks
Active Comparator: Rep
Drug: repaglinide
Administered orally before the three main meals for 24 weeks
Active Comparator: Met+Rep
Drug: metformin
Adminstered orally during the three main meals for 24 weeks
Drug: repaglinide
Administered orally before the three main meals for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Incidence of clinical and/or biochemistry hypoglycaemia episodes
Presence of laboratory abnormalities in routine blood analyses
Change of the blood pressure and/or heart rate
Treatment compliance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2002

Primary Completion (Actual)

October 21, 2004

Study Completion (Actual)

October 21, 2004

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGEE-1411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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