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An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries (BO2NE)

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ClinicalTrials.gov Identifier: NCT00842192
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Design

Study Type : Observational
Actual Enrollment : 2155 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries
Study Start Date : April 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
A Drug: insulin detemir
Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.
Other Names:
  • NN304
  • Levemir®


Outcome Measures

Primary Outcome Measures :
  1. Change in number of hypoglycaemic events from baseline [ Time Frame: at 12 and 24 weeks ]
  2. HbA1c [ Time Frame: at 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects to reach HbA1c between 6.5 and 7.0% [ Time Frame: at 12 and 24 weeks ]
  2. Glucose variability as measured by FPG [ Time Frame: at 12 and 24 weeks ]
  3. Postprandial glycaemic control as measured by PPG [ Time Frame: at 12 and 24 weeks ]
  4. Insulin dose and number of injections [ Time Frame: at 12 and 24 weeks ]
  5. Body weight [ Time Frame: at 12 and 24 weeks ]
  6. Number of adverse drug reactions (ADR) [ Time Frame: at 12 and 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject with type 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.
Criteria

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods
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): NCT00842192


Locations
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Jordan
Novo Nordisk Investigational Site
Amman, Jordan, 11844
Lebanon
Novo Nordisk Investigational Site
Amman, Lebanon, 11844
Pakistan
Novo Nordisk Investigational Site
Karachi, Pakistan
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: NCT00842192     History of Changes
Other Study ID Numbers: NN304-3735
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs