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

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ClinicalTrials.gov Identifier: NCT01526980
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

February 1, 2012
February 6, 2012
January 5, 2017
May 2002
November 2002   (Final data collection date for primary outcome measure)
Glucose average in 24-hour blood glucose profiles
Same as current
Complete list of historical versions of study NCT01526980 on ClinicalTrials.gov Archive Site
  • Pre-meal glucose level
  • Post-meal excursion of glucose (0-4 hours)
  • Cmax, maximum concentration of total insulin
  • tmax, time of maximum concentration of total insulin
  • The area under the 24-hour total insulin concentration time curve
  • Adverse events
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
Intervention Model: Crossover Assignment
Masking: None (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
Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01526980
BIASP-1319
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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