Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes (Start)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486875
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

December 5, 2011
December 5, 2011
January 2006
January 2008   (final data collection date for primary outcome measure)
  • Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Incidence of major hypoglycaemic events [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Number of all hypoglycaemic events [ Time Frame: In the 4 weeks prior to week 12 and week 26, respectively ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes
NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

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

After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily
BIAsp 30
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
1155
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes
Both
18 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01486875
BIASP-1721
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Kerstin Magnusson Novo Nordisk A/S
Novo Nordisk A/S
December 2011

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