Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

NCT ID: NCT01465152

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

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-06

Study Completion Date

2004-10-21

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Met

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

Adminstered orally during the three main meals for 24 weeks

Rep

Group Type ACTIVE_COMPARATOR

repaglinide

Intervention Type DRUG

Administered orally before the three main meals for 24 weeks

Met+Rep

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

Adminstered orally during the three main meals for 24 weeks

repaglinide

Intervention Type DRUG

Administered orally before the three main meals for 24 weeks

Interventions

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metformin

Adminstered orally during the three main meals for 24 weeks

Intervention Type DRUG

repaglinide

Administered orally before the three main meals for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes
* Treated by diet for at least 3 months
* Never treated with hypoglycaemic drugs
* HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria

* Very symptomatic diabetes
* Advanced vascular complications
* Manifest renal failure
* Manifest hepatic disease
* Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods
Minimum Eligible Age

35 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

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Benamargosa, , Spain

Site Status

Novo Nordisk Investigational Site

Burlata, , Spain

Site Status

Novo Nordisk Investigational Site

Camas, , Spain

Site Status

Novo Nordisk Investigational Site

Fuenlabrada, , Spain

Site Status

Novo Nordisk Investigational Site

Gijón, , Spain

Site Status

Novo Nordisk Investigational Site

Granada, , Spain

Site Status

Novo Nordisk Investigational Site

Lugo, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Portugalete, , Spain

Site Status

Novo Nordisk Investigational Site

San Adria Del Besos, , Spain

Site Status

Novo Nordisk Investigational Site

Santander, , Spain

Site Status

Novo Nordisk Investigational Site

Santander, , Spain

Site Status

Novo Nordisk Investigational Site

Tegueste, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Zaragoza, , Spain

Site Status

Countries

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Spain

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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AGEE-1411

Identifier Type: -

Identifier Source: org_study_id

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