Clinical trial NCT00842192: An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 2155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Change in number of hypoglycaemic events from baseline
timeFrame: at 12 and 24 weeks
measure: HbA1c
timeFrame: at 12 and 24 weeks
Secondary outcomes:
measure: Percentage of subjects to reach HbA1c between 6.5 and 7.0%
timeFrame: at 12 and 24 weeks
measure: Glucose variability as measured by FPG
timeFrame: at 12 and 24 weeks
measure: Postprandial glycaemic control as measured by PPG
timeFrame: at 12 and 24 weeks
measure: Insulin dose and number of injections
timeFrame: at 12 and 24 weeks
measure: Body weight
timeFrame: at 12 and 24 weeks
measure: Number of adverse drug reactions (ADR)
timeFrame: at 12 and 24 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Amman
country: Jordan
facility: Novo Nordisk Investigational Site
city: Amman
country: Lebanon
facility: Novo Nordisk Investigational Site
city: Karachi
country: Pakistan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: