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Completed

NCT Number: NCT01355718

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul, 137-920, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repaglinide

Drug

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.

Primary outcomes

  1. Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes

    Time frame: weeks 0-26

Secondary outcomes

  1. Incidence of Adverse Drug Reactions (ADRs)

    Time frame: week 13 and 26

  2. Incidence of Adverse Events (AEs)

    Time frame: week 13 and 26

  3. Incidence of Serious Adverse Event (SAEs)

    Time frame: week 13 and 26

  4. Change in HbA1c

    Time frame: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 18, 2011
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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