Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01698931
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04-26
• Primary Completion: 2003-03-06
• Study Completion: 2003-03-06
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 1	repaglinide	-
Treatment period 1	glyburide	-
Treatment period 1	placebo	-
Treatment period 2	glyburide	-
Treatment period 2	placebo	-
Treatment period 3	placebo	-
Treatment period 2	repaglinide	-
Treatment period 3	repaglinide	-
Treatment period 3	glyburide	-

Primary Outcome Measures

Name	Time	Method
Basal hepatic glucose production	Day 0; day 44

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Day 0; day 44
Number of adverse events	Day 0; day 44
Number of hypoglycaemic episodes	Day 0; day 44

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇹 Padova, Italy