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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: repaglinide

• Registration Number: NCT01355718
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Study Start: 2011-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Repaglinide	repaglinide	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes	weeks 0-26

Secondary Outcome Measures

Name	Time	Method
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