Efficacy of Repaglinide in Subjects With Type 2 Diabetes

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

Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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

  • Italy
      • Padova, Italy, 35137
        • 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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin A1c) above 7 %
  • BMI (body mass index) below 32 kg/m^2
  • FBG (fasting blood glucose) after wash out period 130-220 mg/dl
  • Currently treated with diet or OHA (oral hypoglycaemic agent)

Exclusion Criteria:

  • Current systemic treatment with concomitant medication
  • Known or suspected history of drug or alcohol dependence
  • Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
  • Hepatic disease
  • Cardiac problems
  • Active proliferative retinopathy
  • Known or suspected allergy to trial product or related products
  • Women in fertile age and women having the intention of becoming pregnant
  • Body Mass Index (BMI) above 32 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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment period 1
Drug: repaglinide
1 mg before each main meal on three separate dosing visits separated by a wash-out period
Drug: glyburide
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Drug: placebo
Before each main meal on three separate dosing visits separated by a wash-out period
Active Comparator: Treatment period 2
Drug: repaglinide
1 mg before each main meal on three separate dosing visits separated by a wash-out period
Drug: glyburide
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Drug: placebo
Before each main meal on three separate dosing visits separated by a wash-out period
Placebo Comparator: Treatment period 3
Drug: repaglinide
1 mg before each main meal on three separate dosing visits separated by a wash-out period
Drug: glyburide
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Drug: placebo
Before each main meal on three separate dosing visits separated by a wash-out period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Basal hepatic glucose production
Time Frame: Day 0; day 44
Day 0; day 44

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of hypoglycaemic episodes
Time Frame: Day 0; day 44
Day 0; day 44
Change in body weight
Time Frame: Day 0; day 44
Day 0; day 44
Number of adverse events
Time Frame: Day 0; day 44
Day 0; day 44

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

  • Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)

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)

April 26, 2002

Primary Completion (Actual)

March 6, 2003

Study Completion (Actual)

March 6, 2003

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 3, 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-1259

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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