Text Size

Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00476437
First received: May 21, 2007
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart
Drug: biphasic human insulin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of hypoglycaemic episodes [ Time Frame: During 16 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
  • HbA1C: less than 11.0%
  • BMI: less than 30.0 kg/m2

Exclusion Criteria:

  • Total daily insulin dose: 100 IU/U and more
  • Treatment with oral hypoglycaemic agents within the last 4 weeks.
  • Treatment with insulin sensitizer within the last 12 weeks
  • A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476437

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Muneharu Kagawa Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00476437     History of Changes
Other Study ID Numbers: BIASP-1864, JapicCTI-070408
Study First Received: May 21, 2007
Last Updated: June 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013