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

Diabetes Mellitus, Type 2 Clinical Trial

— BO2NE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842192
• Other study ID #: NN304-3735
• Status: Completed
• Phase: N/A
• First received: February 11, 2009
• Last updated: December 6, 2016
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthPakistan: Ministry of HealthJordan: Ministry of HealthLebanon: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2155
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.

Locations

Country	Name	City	State
Israel	Novo Nordisk Investigational Site	Kfar Saba
Jordan	Novo Nordisk Investigational Site	Amman
Lebanon	Novo Nordisk Investigational Site	Amman
Pakistan	Novo Nordisk Investigational Site	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Israel,  Jordan,  Lebanon,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of hypoglycaemic events from baseline		at 12 and 24 weeks	No
Primary	HbA1c		at 12 and 24 weeks	No
Secondary	Percentage of subjects to reach HbA1c between 6.5 and 7.0%		at 12 and 24 weeks	No
Secondary	Glucose variability as measured by FPG		at 12 and 24 weeks	No
Secondary	Postprandial glycaemic control as measured by PPG		at 12 and 24 weeks	No
Secondary	Insulin dose and number of injections		at 12 and 24 weeks	No
Secondary	Body weight		at 12 and 24 weeks	No
Secondary	Number of adverse drug reactions (ADR)		at 12 and 24 weeks	Yes

External Links

•   Clinical Trials at Novo Nordisk