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Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment (HA-BOT)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00865397
First received: March 18, 2009
Last updated: June 28, 2012
Last verified: March 2012
History of Changes

March 18, 2009
June 28, 2012
February 2009
February 2010   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865397 on ClinicalTrials.gov Archive Site
  • Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5% [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist and hip circumference [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment
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

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

A non-randomised sample of approximately 1000 subjects with OAD failure from specialists - diabetologists practice who have been deemed appropriate to receive insulin detemir as add-on to OAD therapy as part of routine out-patient care by the prescribing physician.
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Other Names:
  • Levemir®
  • NN304
A
Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1032
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00865397
NN304-3699
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Peter Varnai, MD Novo Nordisk Hungary Ltd.
Novo Nordisk
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP