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Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01605773
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: glyburide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repaglinide Versus Glyburide: Comparitive Effect on Postprandial Lipemia: An Open-labeled, Randomized, Parallel Group Study in Patients With Type 2 Diabetes
Study Start Date : November 8, 2001
Actual Primary Completion Date : March 13, 2003
Actual Study Completion Date : March 13, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: repaglinide Drug: repaglinide
Dose individually adjusted and conducted according to labeling
Active Comparator: glyburide Drug: glyburide
Dose individually adjusted and conducted according to labeling



Primary Outcome Measures :
  1. Triglyceride levels post standardised fat tolerance test

Secondary Outcome Measures :
  1. Incidence of hypoglycemic episodes
  2. Change in HbA1c (glycosylated haemoglobin A1c)
  3. Change in FPG (fasting plasma glucose)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
  • Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
  • Males or non-pregnant, non-lactating females
  • Subjects should have normal renal function

Exclusion Criteria:

  • Type 1 or other specific causes of diabetes
  • Marked symptomatic diabetes
  • Uncontrolled treated/untreated hypertension
  • Known or suspected allergy to the trial products or related products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605773


Locations
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01605773     History of Changes
Other Study ID Numbers: AGEE-2137
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 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