Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01605773
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 8, 2001
• Actual Primary Completion Date: Mar 13, 2003
• Actual Study Completion Date: Mar 13, 2003

Arms and Interventions

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

Outcome Measures

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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01605773
• Other Study ID Numbers: AGEE-2137
• First Posted: May 25, 2012
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glyburide; Repaglinide

Study Results

No Results Posted as of Feb 20, 2017