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Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes (DIABESITY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00687063
First received: May 27, 2008
Last updated: August 13, 2014
Last verified: November 2012

May 27, 2008
August 13, 2014
April 2008
February 2009   (final data collection date for primary outcome measure)
Weight change from baseline [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687063 on ClinicalTrials.gov Archive Site
  • Number of serious adverse events [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all adverse events [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all hypoglycemic episodes (24 hr, daytime and nocturnal) [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c change from baseline [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
  • FBG (Fasting Blood Glucose) change from baseline [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 % [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and frequency at the end of the study [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes
An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Type 2 diabetics

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician
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
10008
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any subject with type 2 diabetes

Exclusion Criteria:

  • Subjects with a hypersensitivity to insulin detemir or any of its excipient
  • Children below 6 years
  • Subjects who are pregnant, lactating or planning to become pregnant
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00687063
NN304-3530
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S
Novo Nordisk A/S
November 2012

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