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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00842192

Acronym

BO2NE

Enrollment

2155

Registered

2009-02-12

Start date

2009-04-30

Completion date

2010-08-31

Last updated

2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in number of hypoglycaemic events from baseline	at 12 and 24 weeks
HbA1c	at 12 and 24 weeks

Secondary

Measure	Time frame
Postprandial glycaemic control as measured by PPG	at 12 and 24 weeks
Insulin dose and number of injections	at 12 and 24 weeks
Percentage of subjects to reach HbA1c between 6.5 and 7.0%	at 12 and 24 weeks
Number of adverse drug reactions (ADR)	at 12 and 24 weeks
Body weight	at 12 and 24 weeks
Glucose variability as measured by FPG	at 12 and 24 weeks

Countries

Israel, Jordan, Lebanon, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026