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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 26-week, Multicentre, Open-labelled, Non-randomised, Non-interventional, Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355718
• Other study ID #: AGEE-3905
• Secondary ID: U1111-1119-9152
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: August 8, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: August 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• repaglinide
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes		weeks 0-26	No
Secondary	Incidence of Adverse Drug Reactions (ADRs)		week 13 and 26	No
Secondary	Incidence of Adverse Events (AEs)		week 13 and 26	No
Secondary	Incidence of Serious Adverse Event (SAEs)		week 13 and 26	No
Secondary	Change in HbA1c		after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy	No

External Links

•   Clinical Trials at Novo Nordisk