- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698931
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
-
-
-
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
|
1 mg before each main meal on three separate dosing visits separated by a wash-out period
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Before each main meal on three separate dosing visits separated by a wash-out period
|
Active Comparator: Treatment period 2
|
1 mg before each main meal on three separate dosing visits separated by a wash-out period
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Before each main meal on three separate dosing visits separated by a wash-out period
|
Placebo Comparator: Treatment period 3
|
1 mg before each main meal on three separate dosing visits separated by a wash-out period
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
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
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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