Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Repaglinide

Criteria

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