Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: repaglinide; Drug: glyburide

• Registration Number: NCT01605773
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11-08
• Primary Completion: 2003-03-13
• Study Completion: 2003-03-13
• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repaglinide	repaglinide	-
glyburide	glyburide	-

Primary Outcome Measures

Name	Time	Method
Triglyceride levels post standardised fat tolerance test

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemic episodes
Change in HbA1c (glycosylated haemoglobin A1c)
Change in FPG (fasting plasma glucose)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Houston, Texas, United States