Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

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

Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100730
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100034
        • Novo Nordisk Investigational Site
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Ipoh, Malaysia, 30450
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Novo Nordisk Investigational Site
      • Manila, Philippines, 1003
        • Novo Nordisk Investigational Site
      • Marikina City, Philippines, 1800
        • Novo Nordisk Investigational Site
      • Pampanga, Philippines, 2000
        • Novo Nordisk Investigational Site
      • Quezon, Philippines, 4301
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines, 1100
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10300
        • 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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes for at least 3 months
  • No previous treatment for diabetes
  • HbA1c between 7.0-12.0%
  • Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • Known unstable/untreated proliferative retinopathy
  • Uncontrolled treated/untreated hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 16 weeks of treatment
after 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Adverse events
Quality of life assessment
Hypoglycaemic events
Glucose profiles
Treatment satisfaction

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)

November 21, 2002

Primary Completion (Actual)

November 10, 2003

Study Completion (Actual)

November 10, 2003

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

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-3017

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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