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Observational Study of NovoNorm® in Subjects With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498913
First Posted: December 26, 2011
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 21, 2011
First Posted: December 26, 2011
Last Update Posted: February 20, 2017
Last Verified: February 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