Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGrepaglinide
Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed