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An Observational Study Evaluating Efficacy, Safety and Convenience of NovoNorm® in Treatment of Type 2 Diabetes in Routine Clinical Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498900
First Posted: December 26, 2011
Last Update Posted: October 28, 2016
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 Africa and Asia. The aim of this study is to evaluate the efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes management in routine clinical practice.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoNorm® in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures:
  • Fasting Plasma Glucose (FPG)
  • Postprandial glucose values
  • Incidence of hypoglycaemia
  • Adverse drug reactions (ADR)

Enrollment: 30554
Study Start Date: August 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Repaglinide Drug: repaglinide
Prescription according to the product labelling at the physicians' discretion

  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
Patients with type 2 diabetes, newly diagnosed or not adequately controlled on their current therapy, who are treated repaglinide by their physicians in accordance with the approved labeling
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Newly diagnosed or not adequately controlled with current therapy
  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): NCT01498900


Locations
Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34335
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: NCT01498900     History of Changes
Other Study ID Numbers: AGEE-1875
First Submitted: December 21, 2011
First Posted: December 26, 2011
Last Update Posted: October 28, 2016
Last Verified: October 2016

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