Text Size

Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00842361
First received: February 11, 2009
Last updated: November 9, 2009
Last verified: July 2009
History of Changes
  Purpose

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 on a twice daily regimen in subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN5401
Drug: biphasic insulin aspart 30
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety (With Emphasis on Hypoglycaemia) Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus After 6 Weeks of Treatment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The incidence of hypoglycaemic episodes [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All adverse events [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change in 12-lead ECG [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change in body weight [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN5401
The insulin (NN5401) should be injected subcutaneously immediately before breakfast and dinner.
Active Comparator: B Drug: biphasic insulin aspart 30
The insulin (biphasic insulin aspart 30) should be injected subcutaneously immediately before breakfast and dinner.
Other Names:
  • NovoMix® 30
  • BIASP

  Eligibility

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

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus
  • Current treatment using long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen 12 weeks or longer, with stable insulin dose for the last 4 weeks
  • HbA1C below 10.0%

Exclusion Criteria:

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with total insulin dose of more than 100 U or IU/day
  • Current treatment or expected to start treatment with systemic corticosteroid
  • Treatment with oral anti-diabetic drugs within the last 12 weeks prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842361

Locations
Japan
Chiyoda-ku, Tokyo, Japan, Japan, 100 0005
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Michiaki Kanai 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: NCT00842361     History of Changes
Other Study ID Numbers: NN5401-3570, JAPIC: JapicCTI-090712
Study First Received: February 11, 2009
Last Updated: November 9, 2009
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
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013