This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Observational Study of NovoNorm® in Subjects With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498913
First received: December 21, 2011
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
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 Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NovoNorm Post Marketing Surveillance Study

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Enrollment: 5841
Actual Study Start Date: August 30, 2001
Study Completion Date: March 25, 2005
Primary Completion Date: March 25, 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean people with diabetes mellitus
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498913

Locations
Korea, Republic of
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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01498913     History of Changes
Other Study ID Numbers: AGEE-1882
Study First Received: December 21, 2011
Last Updated: February 17, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017