Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467401
First received: November 4, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 4, 2011
November 4, 2011
August 2002
May 2003   (final data collection date for primary outcome measure)
HbA1c (glycolated haemoglobin) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Prandial increment in blood glucose [ Designated as safety issue: No ]
  • 7-point blood glucose profile [ Designated as safety issue: No ]
  • Number and severity of adverse events [ Designated as safety issue: No ]
  • Number and severity of local tolerability issues at the injection site [ Designated as safety issue: No ]
  • Number and severity of hypoglycaemic episodes [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes
A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart
    Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
  • Drug: biphasic human insulin
    Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
  • Experimental: A
    Intervention: Drug: biphasic insulin aspart
  • Active Comparator: B
    Intervention: Drug: biphasic human insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
May 2003
May 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 24 months
  • Insulin treatment for the pase 3 months
  • HbA1c (glycosylated haemoglobin) below 13%
  • BMI (Body Mass Index) below 40 kg/m^2
  • Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria:

  • Receipt of any investigational drug within 4 weeks prior to this trial
  • Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
  • Total daily insulin dosage less than or equal to 1.8 IU/kg
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
NCT01467401
BIASP-1394
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Marie Bjarnvik Novo Nordisk Scandinavia AB
Novo Nordisk A/S
November 2011

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