An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients
SAFE
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.
2 other identifiers
observational
2,033
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJune 26, 2014
June 1, 2014
11 months
February 26, 2010
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
at Visit 2(8 weeks) and visit 3(16 weeks)
Secondary Outcomes (5)
Number of minor hypoglycaemic (low blood sugar) episodes
at Visit 2(8 weeks) and visit 3(16 weeks)
Number of adverse drug reactions (ADRs)
at Visit 2(8 weeks) and visit 3(16 weeks)
Change in HbA1c
after 16 weeks of treatment
Change in fasting blood glucose (FBG)
after 8 and 16 weeks of treatment
Change in postprandial blood glucose (PBG)
after 8 and 16 weeks treatment
Study Arms (1)
Repaglinide
Interventions
Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study
Eligibility Criteria
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.
You may qualify if:
- HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Beijing, Beijing Municipality, 100004, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 1, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
June 26, 2014
Record last verified: 2014-06