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.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 21, 2011
Last updated: April 11, 2012
Last verified: April 2012

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 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) [ 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


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


Inclusion Criteria:

  • Type 2 diabetes
  • Newly diagnosed or not adequately controlled with current therapy
  Contacts and Locations
Please refer to this study by its identifier: NCT01498900

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

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S 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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014