Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

NCT ID: NCT00568984

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

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-21

Study Completion Date

2003-11-10

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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repaglinide

Intervention Type DRUG

metformin

Intervention Type DRUG

glicazide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least 3 months
* No previous treatment for diabetes
* HbA1c between 7.0-12.0%
* Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria

* Type 1 diabetes
* Known unstable/untreated proliferative retinopathy
* Uncontrolled treated/untreated hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Tianjin, Tianjin Municipality, China

Site Status

Novo Nordisk Investigational Site

Cheras, , Malaysia

Site Status

Novo Nordisk Investigational Site

Ipoh, , Malaysia

Site Status

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Cebu City, , Philippines

Site Status

Novo Nordisk Investigational Site

Manila, , Philippines

Site Status

Novo Nordisk Investigational Site

Marikina City, , Philippines

Site Status

Novo Nordisk Investigational Site

Pampanga, , Philippines

Site Status

Novo Nordisk Investigational Site

Quezon, , Philippines

Site Status

Novo Nordisk Investigational Site

Quezon City, , Philippines

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Countries

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China Malaysia Philippines Thailand

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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AGEE-3017

Identifier Type: -

Identifier Source: org_study_id

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