Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.
Interventions
DRUGrepaglinide
The dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements.
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
* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.) * Patients with type 2 diabetes mellitus * Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD * Age: at least 18 years old * Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician
Exclusion criteria
* Known or suspected allergy to study product(s) or related products * Previous participation in this study. Participation is defined as screened * Patients who have been treated with insulin preparations (including insulin analogues) previously * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) * Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit * Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes | weeks 0-26 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | week 13 and 26 |
| Incidence of Adverse Events (AEs) | week 13 and 26 |
| Incidence of Serious Adverse Event (SAEs) | week 13 and 26 |
| Change in HbA1c | after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy |
Countries
South Korea
Outcome results
None listed