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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467401
First Posted: November 8, 2011
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
November 4, 2011
November 8, 2011
February 24, 2017
August 19, 2002
May 15, 2003   (Final data collection date for primary outcome measure)
HbA1c (glycolated haemoglobin)
Same as current
Complete list of historical versions of study NCT01467401 on ClinicalTrials.gov Archive Site
  • Prandial increment in blood glucose
  • 7-point blood glucose profile
  • Number and severity of adverse events
  • Number and severity of local tolerability issues at the injection site
  • Number and severity of hypoglycaemic episodes
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
Intervention Model: Parallel Assignment
Masking: None (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 15, 2003
May 15, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
 
NCT01467401
BIASP-1394
No
Not Provided
Not Provided
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
February 2017

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