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

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.
ClinicalTrials.gov Identifier: NCT01467401
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Drug: biphasic human insulin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 19, 2002
Primary Completion Date : May 15, 2003
Study Completion Date : May 15, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: biphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
Active Comparator: B Drug: biphasic human insulin
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily


Outcome Measures

Primary Outcome Measures :
  1. HbA1c (glycolated haemoglobin)

Secondary Outcome Measures :
  1. Prandial increment in blood glucose
  2. 7-point blood glucose profile
  3. Number and severity of adverse events
  4. Number and severity of local tolerability issues at the injection site
  5. Number and severity of hypoglycaemic episodes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467401


  Hide Study Locations
Locations
Denmark
Novo Nordisk Investigational Site
Esbjerg, Denmark, 6700
Novo Nordisk Investigational Site
Herning, Denmark, 7400
Novo Nordisk Investigational Site
Holbæk, Denmark, 4300
Novo Nordisk Investigational Site
Næstved, Denmark, 4700
Novo Nordisk Investigational Site
Randers, Denmark
Novo Nordisk Investigational Site
Silkeborg, Denmark, 8600
Novo Nordisk Investigational Site
Skive, Denmark, 7800
Novo Nordisk Investigational Site
Viborg, Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Norway
Novo Nordisk Investigational Site
Bekkestua, Norway, 1357
Novo Nordisk Investigational Site
Bergen, Norway, NO-5012
Novo Nordisk Investigational Site
Haugesund, Norway
Novo Nordisk Investigational Site
Hønefoss, Norway
Novo Nordisk Investigational Site
Moelv, Norway
Novo Nordisk Investigational Site
Oslo, Norway, 0370
Novo Nordisk Investigational Site
Tromsø, Norway, 9038
Novo Nordisk Investigational Site
Vennesla, Norway
Novo Nordisk Investigational Site
Åsgårdstrand, Norway
Sweden
Novo Nordisk Investigational Site
Arvika, Sweden, 671 80
Novo Nordisk Investigational Site
Avesta, Sweden, 774 82
Novo Nordisk Investigational Site
Bjuv, Sweden, 267 38
Novo Nordisk Investigational Site
Broby, Sweden, 280 60
Novo Nordisk Investigational Site
Färgelanda, Sweden, 458 32
Novo Nordisk Investigational Site
Grästorp, Sweden, 467 22
Novo Nordisk Investigational Site
Göteborg, Sweden, 416 65
Novo Nordisk Investigational Site
Göteborg, Sweden, 416 85
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 02
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 17
Novo Nordisk Investigational Site
Habo, Sweden, 566 32
Novo Nordisk Investigational Site
Helsingborg, Sweden, 254 57
Novo Nordisk Investigational Site
Härnösand, Sweden, 871 82
Novo Nordisk Investigational Site
Hässleholm, Sweden, 281 25
Novo Nordisk Investigational Site
Jönköping, Sweden, 551 11
Novo Nordisk Investigational Site
Karlstad, Sweden, 651 85
Novo Nordisk Investigational Site
Karlstad, Sweden, 652 24
Novo Nordisk Investigational Site
Kristianstad, Sweden, 291 38
Novo Nordisk Investigational Site
Kristinehamn, Sweden, 681 80
Novo Nordisk Investigational Site
Kungsbacka, Sweden, 434 80
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Novo Nordisk Investigational Site
Mellerud, Sweden, 464 30
Novo Nordisk Investigational Site
Mölndal, Sweden, 431 80
Novo Nordisk Investigational Site
Norrköping, Sweden, 602 36
Novo Nordisk Investigational Site
Skövde, Sweden, 541 85
Novo Nordisk Investigational Site
Stockholm, Sweden, 116 91
Novo Nordisk Investigational Site
Säffle, Sweden, 661 81
Novo Nordisk Investigational Site
Tomelilla, Sweden, 273 34
Novo Nordisk Investigational Site
Torsby, Sweden, 685 29
Novo Nordisk Investigational Site
Trollhättan, Sweden, 461 40
Novo Nordisk Investigational Site
Trollhättan, Sweden, 461 85
Novo Nordisk Investigational Site
Tyresö, Sweden, 135 21
Novo Nordisk Investigational Site
Uddevalla, Sweden, 451 80
Novo Nordisk Investigational Site
Värnamo, Sweden, 331 85
Novo Nordisk Investigational Site
Örebro, Sweden, 701 85
Novo Nordisk Investigational Site
Örebro, Sweden, 702 15
Novo Nordisk Investigational Site
Örebro, Sweden, 703 51
Novo Nordisk Investigational Site
Östersund, Sweden, 831 62
Novo Nordisk Investigational Site
Östersund, Sweden, 831 83
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467401     History of Changes
Other Study ID Numbers: BIASP-1394
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs