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
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: biphasic human insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycolated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 292
Study Start Date: August 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467401

Locations
Denmark
Næstved, Denmark, 4700
Norway
Bergen, Norway, NO-5012
Sweden
Trollhättan, Sweden, 461 40
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marie Bjarnvik Novo Nordisk Scandinavia AB
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467401     History of Changes
Other Study ID Numbers: BIASP-1394
Study First Received: November 4, 2011
Last Updated: November 4, 2011
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014