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

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

A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

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, 100101
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200433
        • 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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HbA1c between 7.5 % and 13.0% (both inclusive)
  • Fasting C-peptide above or equal to 0.33 nmol/l
  • BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion Criteria:

  • Medical history of treatment with insulin within the last 6 months
  • Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rep + NPH
Drug: repaglinide
2 mg (tablets) before each main meal
Drug: isophane human insulin
Injection s.c. (under the skin) at bedtime
ACTIVE_COMPARATOR: Premixed insulin/NPH
Drug: insulin
Injection s.c. (under the skin) twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in HbA1c

Secondary Outcome Measures

Outcome Measure
Change in body weight
Change in FBG (Fasting Blood Glucose)

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)

September 19, 2002

Primary Completion (ACTUAL)

April 10, 2003

Study Completion (ACTUAL)

April 10, 2003

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (ESTIMATE)

November 2, 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-3020

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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