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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

February 11, 2009
November 9, 2009
January 2009
June 2009   (final data collection date for primary outcome measure)
The incidence of hypoglycaemic episodes [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00842361 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: NN5401
    The insulin (NN5401) should be injected subcutaneously immediately before breakfast and dinner.
  • 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
  • Experimental: A
    Intervention: Drug: NN5401
  • Active Comparator: B
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00842361
NN5401-3570, JAPIC: JapicCTI-090712
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Michiaki Kanai Novo Nordisk Pharma Ltd.
Novo Nordisk
July 2009

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