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:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00842192
First received: February 11, 2009
Last updated: June 28, 2012
Last verified: April 2012
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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:
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:
|
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
Investigators
| Study Director: | Elif Coskuncay Yener, MD | Novo Nordisk Regional Office Near East |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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 May 21, 2013