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Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus (LevSafeQD)
This study is ongoing, but not recruiting participants.
Study NCT00709475   Information provided by Novo Nordisk
First Received: June 30, 2008   Last Updated: October 30, 2009   History of Changes

June 30, 2008
October 30, 2009
May 2008
December 2009   (final data collection date for primary outcome measure)
Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events [ Time Frame: For the duration of the study (32 weeks) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00709475 on ClinicalTrials.gov Archive Site
  • Number of serious adverse events [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
  • Number of all adverse events [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
  • Number of all - daytime and nocturnal - hypoglycaemic events [ Time Frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits ] [ Designated as safety issue: Yes ]
  • Weight changes compared to baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • HbA1c compared to baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Fasting glucose level control compared to baseline as measured by FBG [ Time Frame: After 16 and 32 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
 
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

 
 
Observational
Cohort, Prospective
Diabetes Mellitus, Type 2
Drug: insulin detemir
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
500
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit;
  • Subjects currently being treated with insulin detemir;
  • Subjects who previously enrolled in this study or studies related to NovoMix 30;
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT00709475
Public Access to Clinical Trials, Novo Nordisk A/S
NN304-3551
Novo Nordisk
 
Study Director: Waleed AbdelFattah, MD Novo Nordisk Gulf
Study Director: Hani Bakry, MSc Pharm Novo Nordisk Gulf
Novo Nordisk
October 2009

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