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Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01605773
First received: May 16, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Triglyceride levels post standardised fat tolerance test [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of hypoglycemic episodes [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]
  • Change in FPG (fasting plasma glucose) [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2001
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605773

Locations
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Paula Hale Novo Nordisk
  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: NCT01605773     History of Changes
Other Study ID Numbers: AGEE-2137
Study First Received: May 16, 2012
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

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 June 18, 2013