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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01355718
First received: May 13, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: week 13 and 26 ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs) [ Time Frame: week 13 and 26 ] [ Designated as safety issue: No ]
  • Incidence of Serious Adverse Event (SAEs) [ Time Frame: week 13 and 26 ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Repaglinide 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355718

Locations
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01355718     History of Changes
Other Study ID Numbers: AGEE-3905, U1111-1119-9152
Study First Received: May 13, 2011
Last Updated: February 28, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014