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

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide

Study type: Observational

Funder types: Industry

Identifiers

NCT01355718

AGEE-3905

U1111-1119-9152 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Repaglinide

Treatment:

Drug: repaglinide