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

August 8, 2014 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
Time Frame: weeks 0-26
weeks 0-26

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Drug Reactions (ADRs)
Time Frame: week 13 and 26
week 13 and 26
Incidence of Adverse Events (AEs)
Time Frame: week 13 and 26
week 13 and 26
Incidence of Serious Adverse Event (SAEs)
Time Frame: week 13 and 26
week 13 and 26
Change in HbA1c
Time Frame: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGEE-3905
  • U1111-1119-9152 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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