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Efficacy of Repaglinide in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01698931
First received: October 1, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: repaglinide
Drug: glyburide
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Basal hepatic glucose production [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Number of adverse events [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: April 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698931

Locations
Italy
Padova, Italy, 35137
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Letizia Vitali Novo Nordisk Farmaceutici SpA
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01698931     History of Changes
Other Study ID Numbers: AGEE-1259
Study First Received: October 1, 2012
Last Updated: October 1, 2012
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Repaglinide
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013