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Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes (INTENSIV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00704223
First received: June 20, 2008
Last updated: June 23, 2014
Last verified: June 2014

June 20, 2008
June 23, 2014
May 2008
November 2008   (final data collection date for primary outcome measure)
number of major and minor hypoglycaemic events and adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00704223 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PPBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • FBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes
Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample

Probability Sample

Male and female above 18 years with type 2 diabetes

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation
Other Name: NovoMix® 70
A
Intervention: Drug: biphasic insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
619
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c over 7%
  • No contraindication with NovoMix® 70

Exclusion Criteria:

  • Type 1 diabetes
  • Subjects participating in a clinical trial or another observational study
  • Subjects under previous basis-bolus insulin therapy
  • Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00704223
BIASP-3576
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

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