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: August 8, 2014
Last verified: August 2014

May 13, 2011
August 8, 2014
August 2011
March 2013   (final data collection date for primary outcome measure)
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01355718 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of Adverse Drug Reations (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 ]
Not Provided
Not Provided
 
Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 2
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.
Repaglinide
Intervention: Drug: repaglinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01355718
AGEE-3905, U1111-1119-9152
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP