Observational Study of NovoNorm® in Subjects With Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01498913
Collaborator
(none)
5,841
1
42.8
136.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
5841 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
NovoNorm Post Marketing Surveillance Study
Actual Study Start Date
:
Aug 30, 2001
Actual Primary Completion Date
:
Mar 25, 2005
Actual Study Completion Date
:
Mar 25, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Repaglinide
|
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
|
Outcome Measures
Primary Outcome Measures
- HbA1c (glycosylated haemoglobin) []
- 2 hours postprandial blood glucose (2-hr PPBG) []
- Fasting blood glucose (FBG) []
- Body weight []
Secondary Outcome Measures
- Adverse events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Type 2 diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 137-920 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498913
Other Study ID Numbers:
- AGEE-1882
First Posted:
Dec 26, 2011
Last Update Posted:
Feb 20, 2017
Last Verified:
Feb 1, 2017