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Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00709683
First received: July 1, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes

July 1, 2008
June 5, 2012
May 2008
May 2009   (final data collection date for primary outcome measure)
Incidence of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00709683 on ClinicalTrials.gov Archive Site
  • Number of serious adverse drug reactions [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of serious adverse events [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Weight (BMI) change from baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]
  • HbA1c change from baseline [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c of less than or equal to 7.0% [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Average (mean) fasting plasma glucose level [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®
An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Type 2 diabetic patients
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30
A
Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes having failed on basal insulin with or without OAD
  • HbA1c greater than 7.0%

Exclusion Criteria:

  • Subjects being unlikely to comply with protocol requirements
  • Subjects who previously enrolled in this study
  • Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
  • Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Tunisia
 
NCT00709683
BIASP-3572
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Lars Lehmann, Biologist Novo Nordisk A/S - ROAG
Novo Nordisk
June 2012

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