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Clinical Trials/NCT00842192
NCT00842192CompletedNot Applicable

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

Novo Nordisk A/S1 site in 1 country2,155 target enrollmentStarted: April 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,155
Locations
1
Primary Endpoint
Change in number of hypoglycaemic events from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Intervention: insulin detemir (Drug)

Outcomes

Primary Outcomes

Change in number of hypoglycaemic events from baseline

Time Frame: at 12 and 24 weeks

HbA1c

Time Frame: at 12 and 24 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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