Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

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

Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin

This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 3

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

  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
  • Philippines
      • Marikina City, Philippines, 1800
        • Novo Nordisk Investigational Site
      • Pasig City, Philippines, 1605
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines, 1100
        • Novo Nordisk Investigational Site
  • South Africa
      • Alberton, South Africa, 1449
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7460
        • Novo Nordisk Investigational Site
  • Taiwan
      • Tainan city, Taiwan, 710
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
  • BMI (body mass index) maximum 35 kg/m^2

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: Rep + NPH
Drug: repaglinide
2 mg at each main meal
Drug: insulin NPH
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
Active Comparator: NPH
Drug: insulin NPH
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c (glycosylated haemoglobin)
Time Frame: Week 0 (visit 5); week 26
Week 0 (visit 5); week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
FPG (fasting plasma glucose)
Time Frame: Week 0 (visit 5); week 26
Week 0 (visit 5); week 26
7-point blood glucose profile
Time Frame: Week 0 (visit 5); week 26
Week 0 (visit 5); week 26
Hypoglycaemic episodes
Time Frame: Week 0 (visit 5); week 26
Week 0 (visit 5); week 26
Adverse events
Time Frame: Week 0 (Visit 5); week 26
Week 0 (Visit 5); week 26

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.

General Publications

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)

June 1, 2001

Primary Completion (Actual)

December 20, 2002

Study Completion (Actual)

December 20, 2002

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

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-1272

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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