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Completed

NCT Number: NCT00842192

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Kfar Saba, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

Other names: NN304, Levemir®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: BO2NE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 12, 2009
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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