Back to resultsEfficacy of Repaglinide in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
repaglinide
glyburide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Treatment period 1
Treatment period 2
Treatment period 3
Arm Description
Outcomes
Primary Outcome Measures
Basal hepatic glucose production
Secondary Outcome Measures
Number of hypoglycaemic episodes
Change in body weight
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01698931
Brief Title
Efficacy of Repaglinide in Subjects With Type 2 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 26, 2002 (Actual)
Primary Completion Date
March 6, 2003 (Actual)
Study Completion Date
March 6, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment period 1
Arm Type
Experimental
Arm Title
Treatment period 2
Arm Type
Active Comparator
Arm Title
Treatment period 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
repaglinide
Intervention Description
1 mg before each main meal on three separate dosing visits separated by a wash-out period
Intervention Type
Drug
Intervention Name(s)
glyburide
Intervention Description
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Before each main meal on three separate dosing visits separated by a wash-out period
Primary Outcome Measure Information:
Title
Basal hepatic glucose production
Time Frame
Day 0; day 44
Secondary Outcome Measure Information:
Title
Number of hypoglycaemic episodes
Time Frame
Day 0; day 44
Title
Change in body weight
Time Frame
Day 0; day 44
Title
Number of adverse events
Time Frame
Day 0; day 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Padova
ZIP/Postal Code
35137
Country
Italy
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy of Repaglinide in Subjects With Type 2 Diabetes
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