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Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01526980
First received: February 1, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 1, 2012
February 1, 2012
May 2002
November 2002   (final data collection date for primary outcome measure)
Glucose average in 24-hour blood glucose profiles [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Pre-meal glucose level [ Designated as safety issue: No ]
  • Post-meal excursion of glucose (0-4 hours) [ Designated as safety issue: No ]
  • Cmax, maximum concentration of total insulin [ Designated as safety issue: No ]
  • tmax, time of maximum concentration of total insulin [ Designated as safety issue: No ]
  • The area under the 24-hour total insulin concentration time curve [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart 30
    Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
  • Drug: biphasic insulin aspart 70
    Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
  • Drug: biphasic human insulin 30
    Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
  • Experimental: Treatment period 1
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic insulin aspart 70
    • Drug: biphasic human insulin 30
  • Active Comparator: Treatment period 2
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic insulin aspart 70
    • Drug: biphasic human insulin 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2002
November 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with Type 2 diabetes
  • Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
  • HbA1c maximum 10.0%
  • BMI (Body Mass Index) maximum 35.0 kg/m2
  • Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose minimum 2.0 U/(kg·day)
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Severe, uncontrolled hypertension
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01526980
BIASP-1319
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Benedikte Lertoft Novo Nordisk
Novo Nordisk
February 2012

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