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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
ClinicalTrials.gov Identifier:
NCT01355718
First received: May 13, 2011
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

This trial is conducted in Asia. The aim of this study is to evaluate the experience with NovoNorm® and insulin analogue combination therapy when used under normal clinical practice conditions in Korea.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
 Drug: No treatment given

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:

Drug Information available for: Repaglinide
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
A Drug: No treatment given
The dosage and frequency, as well as later changes to either dose or frequency (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:

  • Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD.
  • Patients who will be prescribed insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion of the Physician.

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products.
  • Previous participation in this study.
  • 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).
  • Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results.
  Contacts and Locations
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
Investigators
Study Director: Shichihiro Takahashi Novo Nordisk Pharma Ltd.
Study Director: MinJung Kim Novo Nordisk Pharma Korea Ltd
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01355718     History of Changes
Other Study ID Numbers: AGEE-3905, U1111-1119-9152
Study First Received: May 13, 2011
Last Updated: April 10, 2013
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 May 16, 2013