- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498900
An Observational Study Evaluating Efficacy, Safety and Convenience of NovoNorm® in Treatment of Type 2 Diabetes in Routine Clinical Practice
October 26, 2016 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30554
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34335
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Type 2 diabetes
- Newly diagnosed or not adequately controlled with current therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Repaglinide
|
Prescription according to the product labelling at the physicians' discretion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
HbA1c (glycosylated haemoglobin)
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse drug reactions (ADR)
|
Fasting Plasma Glucose (FPG)
|
Postprandial glucose values
|
Incidence of hypoglycaemia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
December 21, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 26, 2011
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGEE-1875
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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