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Clinical Trials/NCT00865397
NCT00865397
Completed
Not Applicable

Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary

Novo Nordisk A/S1 site in 1 country1,032 target enrollmentStarted: February 2009Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 2
Interventionsinsulin detemir
Drugsinsulin detemir

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1,032
Locations
1
Primary Endpoint
Change in HbA1c
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
  • •Patient willing to sign informed consent
  • •Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria

  • •Subjects with diagnosed type 1 diabetes mellitus
  • •Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
  • •Subjects with hypersensitivity to Levemir® or to any of the ingredients
  • •Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

Arms & Interventions

A

Intervention: insulin detemir (Drug)

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: after 24 weeks

Secondary Outcomes

  • Change in body weight(after 12 weeks and 24 weeks)
  • Change in waist and hip circumference(after 12 weeks and 24 weeks)
  • Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5%(after 12 weeks and 24 weeks)
  • Change in FPG (Fasting Plasma Glucose)(after 12 weeks and 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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