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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842192
First received: February 11, 2009
Last updated: June 28, 2012
Last verified: April 2012
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in number of hypoglycaemic events from baseline [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects to reach HbA1c between 6.5 and 7.0% [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Glucose variability as measured by FPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Postprandial glycaemic control as measured by PPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and number of injections [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2154
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842192

Locations
Israel
Kfar Saba, Israel, 44425
Jordan
Amman, Jordan, 11844
Lebanon
Amman, Lebanon, 11844
Pakistan
Karachi, Pakistan
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Elif Coskuncay Yener, MD Novo Nordisk Regional Office Near East
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00842192     History of Changes
Other Study ID Numbers: NN304-3735
Study First Received: February 11, 2009
Last Updated: June 28, 2012
Health Authority: Israel: Ministry of Health
Pakistan: Ministry of Health
Jordan: Ministry of Health
Lebanon: Ministry of Public Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014