Efficacy of Repaglinide in Subjects With Type 2 Diabetes

NCT ID: NCT01698931

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-26

Study Completion Date

2003-03-06

Brief Summary

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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

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment period 1

Group Type EXPERIMENTAL

repaglinide

Intervention Type DRUG

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

glyburide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Treatment period 2

Group Type ACTIVE_COMPARATOR

repaglinide

Intervention Type DRUG

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

glyburide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Treatment period 3

Group Type PLACEBO_COMPARATOR

repaglinide

Intervention Type DRUG

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

glyburide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Interventions

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repaglinide

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

Intervention Type DRUG

glyburide

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Padua, , Italy

Site Status

Countries

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Italy

References

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Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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AGEE-1259

Identifier Type: -

Identifier Source: org_study_id

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