Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin (Mix2Mix)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00775736
First received: October 17, 2008
Last updated: June 15, 2012
Last verified: June 2012

October 17, 2008
June 15, 2012
October 2008
January 2011   (final data collection date for primary outcome measure)
The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00775736 on ClinicalTrials.gov Archive Site
  • Number of all hypoglycaemic episodes. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]
  • Number of all adverse drug reactions. [ Time Frame: At baseline, 12 and 26 weeks. ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Weight changes [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin
Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

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

After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart 30
    Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
    Other Name: BIAsp
  • Drug: biphasic insulin aspart 50
    Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
  • Drug: biphasic insulin aspart 70
    Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
A
Interventions:
  • Drug: biphasic insulin aspart 30
  • Drug: biphasic insulin aspart 50
  • Drug: biphasic insulin aspart 70
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
611
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • Known or suspected allergy to study product or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Luxembourg
 
NCT00775736
BIASP-3665
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Dirk D'Hooge, MD sa Novo Nordisk Pharma
Novo Nordisk A/S
June 2012

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