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
Change in HbA1c	after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
Incidence of Adverse Events (AEs)	week 13 and 26
Incidence of Serious Adverse Event (SAEs)	week 13 and 26