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NCT01498913 Clinical Trial

Observational Study of NovoNorm® in Subjects With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
NovoNorm Post Marketing Surveillance Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01498913
Other study ID # AGEE-1882
Secondary ID
Status Completed
Phase N/A
First received December 21, 2011
Last updated February 17, 2017
Start date August 30, 2001
Est. completion date March 25, 2005

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.

Recruitment information / eligibility
Status Completed
Enrollment 5841
Est. completion date March 25, 2005
Est. primary completion date March 25, 2005
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide
Prescription with NovoNorm® 0.5mg, 1mg or 2mg tablets according to product labelling in daily clinical practice at the discretion of the physician

Locations
Country Name City State
Korea, Republic of Novo Nordisk Investigational Site Seoul

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin)
Primary 2 hours postprandial blood glucose (2-hr PPBG)
Primary Fasting blood glucose (FBG)
Primary Body weight
Secondary Adverse events
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