An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients

NCT ID: NCT01077570

Last Updated: 2014-06-26

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

Total Enrollment

2033 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Repaglinide

repaglinide

Intervention Type DRUG

Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

Interventions

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repaglinide

Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study

Exclusion Criteria

* Subjects who received any anti-diabetic treatment previously
* Known or suspected allergy to trial product(s) or related products.
* Subjects who previously enrolled in this study.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Minimum Eligible Age

18 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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Beijing, Beijing Municipality, China

Site Status

Countries

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China

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1112-6394

Identifier Type: OTHER

Identifier Source: secondary_id

AGEE-3822

Identifier Type: -

Identifier Source: org_study_id

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