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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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01498900
First received: December 21, 2011
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  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:

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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Plasma Glucose (FPG) [ Designated as safety issue: No ]
  • Postprandial glucose values [ Designated as safety issue: No ]
  • Incidence of hypoglycaemia [ Designated as safety issue: No ]
  • Adverse drug reactions (ADR) [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498900

Locations
China, Beijing
Beijing, Beijing, China, 100004
Iraq
Amman, Iraq, 11844
Jordan
Amman, Jordan, 11844
Lebanon
Amman, Lebanon, 11844
Morocco
Casablanca, Morocco, 20000
Turkey
Istanbul, Turkey, 34335
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Senior Project Manager for OADs Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01498900     History of Changes
Other Study ID Numbers: AGEE-1875
Study First Received: December 21, 2011
Last Updated: April 11, 2012
Health Authority: China: Food and Drug Administration
Iraq: Ministry of Health
Jordan: Ministry of Health
Lebanon: Ministry of Public Health
Morocco: Ministry of Health
Turkey: Ministry of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013