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Efficacy of Repaglinide in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01698931
First received: October 1, 2012
Last updated: February 17, 2017
Last verified: February 2017
  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
Intervention Model: Crossover Assignment
Masking: No masking
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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Basal hepatic glucose production [ Time Frame: Day 0; day 44 ]

Secondary Outcome Measures:
  • Number of hypoglycaemic episodes [ Time Frame: Day 0; day 44 ]
  • Change in body weight [ Time Frame: Day 0; day 44 ]
  • Number of adverse events [ Time Frame: Day 0; day 44 ]

Enrollment: 9
Actual Study Start Date: April 26, 2002
Study Completion Date: March 6, 2003
Primary Completion Date: March 6, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698931

Locations
Italy
Novo Nordisk Investigational Site
Padova, Italy, 35137
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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)

Responsible Party: 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: February 17, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017