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

June 25, 2014 updated by: Novo Nordisk A/S

The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2033

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive Repaglinide as initial treatment and as part of routine out-patient care by the prescribing physician.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Repaglinide
Drug: repaglinide
Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
Time Frame: at Visit 2(8 weeks) and visit 3(16 weeks)
at Visit 2(8 weeks) and visit 3(16 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of minor hypoglycaemic (low blood sugar) episodes
Time Frame: at Visit 2(8 weeks) and visit 3(16 weeks)
at Visit 2(8 weeks) and visit 3(16 weeks)
Number of adverse drug reactions (ADRs)
Time Frame: at Visit 2(8 weeks) and visit 3(16 weeks)
at Visit 2(8 weeks) and visit 3(16 weeks)
Change in HbA1c
Time Frame: after 16 weeks of treatment
after 16 weeks of treatment
Change in fasting blood glucose (FBG)
Time Frame: after 8 and 16 weeks of treatment
after 8 and 16 weeks of treatment
Change in postprandial blood glucose (PBG)
Time Frame: after 8 and 16 weeks treatment
after 8 and 16 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGEE-3822
  • U1111-1112-6394 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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