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Observational Study of NovoNorm® in Subjects With Diabetes

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ClinicalTrials.gov Identifier: NCT01498913
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide

Study Type : Observational
Actual Enrollment : 5841 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NovoNorm Post Marketing Surveillance Study
Actual Study Start Date : August 30, 2001
Actual Primary Completion Date : March 25, 2005
Actual Study Completion Date : March 25, 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Repaglinide
U.S. FDA Resources

Group/Cohort 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



Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)
  2. 2 hours postprandial blood glucose (2-hr PPBG)
  3. Fasting blood glucose (FBG)
  4. Body weight

Secondary Outcome Measures :
  1. Adverse events


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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01498913     History of Changes
Other Study ID Numbers: AGEE-1882
First Posted: December 26, 2011    Key Record Dates
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