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Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00655200
First received: April 4, 2008
Last updated: July 24, 2012
Last verified: July 2012
History of Changes

April 4, 2008
July 24, 2012
February 2008
September 2008   (final data collection date for primary outcome measure)
Safety profile of Insulin Detemir among Filipino patients [ Time Frame: 3 months follow-up visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655200 on ClinicalTrials.gov Archive Site
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Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

Patients with Type 1 and Type 2 Diabetes
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: Levemir™
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
3299
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
  • Newly diagnosed insulin naive patients
  • Patients currently on human insulin or on basal insulin
  • Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
  • Usage should be in accordance with the current prescribing information (See attached prescribing information)

Exclusion Criteria:

  • Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
  • Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
  • Pregnant women, those planning to become pregnant, or women who are breastfeeding
  • Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
  • Children below 6 years old
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00655200
NN304-3525
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Dixie Pritzel C. Calpatura Novo Nordisk
Novo Nordisk
July 2012

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