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Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes (PREDICTIVE™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00655044
First received: April 4, 2008
Last updated: August 13, 2014
Last verified: November 2012

April 4, 2008
August 13, 2014
May 2007
January 2008   (final data collection date for primary outcome measure)
HbA1C [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655044 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.

Not Provided
Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample

Type 1 and type 2 diabetes patients

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
Other Names:
  • Levemir®
  • NN304
Type 1 and type 2 diabetes patients
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
3637
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes
  • Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

  • Unwilling to adhere to therapy or follow up
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00655044
NN304-3514
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Akeel Ballan, RN/MSc/BAcom Novo Nordisk Russia
Novo Nordisk A/S
November 2012

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