Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01698931

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: repaglinide Drug: glyburide Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial

Actual Study Start Date :

Apr 26, 2002

Actual Primary Completion Date :

Mar 6, 2003

Actual Study Completion Date :

Mar 6, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment period 1	Drug: repaglinide 1 mg before each main meal on three separate dosing visits separated by a wash-out period Drug: glyburide 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period Drug: placebo Before each main meal on three separate dosing visits separated by a wash-out period
Active Comparator: Treatment period 2	Drug: repaglinide 1 mg before each main meal on three separate dosing visits separated by a wash-out period Drug: glyburide 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period Drug: placebo Before each main meal on three separate dosing visits separated by a wash-out period
Placebo Comparator: Treatment period 3	Drug: repaglinide 1 mg before each main meal on three separate dosing visits separated by a wash-out period Drug: glyburide 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period Drug: placebo Before each main meal on three separate dosing visits separated by a wash-out period

Arm

Intervention/Treatment

Experimental: Treatment period 1

Drug: repaglinide

1 mg before each main meal on three separate dosing visits separated by a wash-out period

Drug: glyburide

5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period

Drug: placebo

Before each main meal on three separate dosing visits separated by a wash-out period

Active Comparator: Treatment period 2

Drug: repaglinide

1 mg before each main meal on three separate dosing visits separated by a wash-out period

Drug: glyburide

5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period

Drug: placebo

Before each main meal on three separate dosing visits separated by a wash-out period

Placebo Comparator: Treatment period 3

Drug: repaglinide

1 mg before each main meal on three separate dosing visits separated by a wash-out period

Drug: glyburide

5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period

Drug: placebo

Before each main meal on three separate dosing visits separated by a wash-out period

Outcome Measures

Primary Outcome Measures

Basal hepatic glucose production [Day 0; day 44]

Secondary Outcome Measures

Number of hypoglycaemic episodes [Day 0; day 44]
Change in body weight [Day 0; day 44]
Number of adverse events [Day 0; day 44]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Padova		Italy	35137

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:

NCT01698931

Other Study ID Numbers:

AGEE-1259

First Posted:

Oct 3, 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