An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients
- Registration Number
- NCT01077570
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2033
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Repaglinide repaglinide -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 postprandial blood glucose (PBG) after 8 and 16 weeks treatment Change in fasting blood glucose (FBG) after 8 and 16 weeks of treatment