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

NCT01355718 | Completed

• 2 other identifiers: AGEE-3905U1111-1119-9152
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

  weeks 0-26

Secondary Outcomes (4)

• Incidence of Adverse Drug Reactions (ADRs)

  week 13 and 26

• Incidence of Adverse Events (AEs)

  week 13 and 26

• Incidence of Serious Adverse Event (SAEs)

  week 13 and 26

• Change in HbA1c

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

Study Arms (1)

Repaglinide

Drug: repaglinide

Interventions

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.

Repaglinide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Seoul, 137-920, South Korea

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

repaglinide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 18, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

KR (1)