Clinical trial NCT01355718: Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD (thiazolidinedione) and will be additionally prescribed with insulin analogue at the discretion of the physicians will be eligible for this study.

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.


Eligibility 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

Primary outcomes:
measure: Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
timeFrame: weeks 0-26
Secondary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: week 13 and 26
measure: Incidence of Adverse Events (AEs)
timeFrame: week 13 and 26
measure: Incidence of Serious Adverse Event (SAEs)
timeFrame: week 13 and 26
measure: Change in HbA1c
timeFrame: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: