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Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00978627
First received: September 16, 2009
Last updated: September 21, 2011
Last verified: September 2011
History of Changes

September 16, 2009
September 21, 2011
August 2009
May 2010   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00978627 on ClinicalTrials.gov Archive Site
  • Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Self measured 9-point plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes (BOOST™: T1)

This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 with insulin detemir plus insulin aspart in patients with type 1 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: NN5401
    NN5401 injected subcutaneously (under the skin) with a meal. The dose will be individually adjusted.
  • Drug: insulin detemir
    Insulin detemir injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
  • Drug: insulin aspart

    When administered in combination with NN5401, insulin aspart is injected subcutaneously (under the skin) at the remaining meals.

    The dose will be individually adjusted.

  • Drug: insulin aspart

    When administered in combination with insulin detemir, insulin aspart is injected subcutaneously (under the skin) at the meals.

    The dose will be individually adjusted.
  • Experimental: A
    Interventions:
    • Drug: NN5401
    • Drug: insulin aspart
  • Active Comparator: B
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek E, Hermansen K, King A, Mersebach H, Davies M. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012 Nov;35(11):2174-81. doi: 10.2337/dc11-2503. Epub 2012 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
548
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
  • HbA1c 7.0-10.0% (both inclusive)
  • BMI (Body Mass Index) below or equal to 35.0 kg/m2

Exclusion Criteria:

  • Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Denmark,   France,   Israel,   Poland,   Puerto Rico,   Russian Federation,   United Kingdom
 
NCT00978627
NN5401-3594, 2008-005769-71, U1111-1111-8943
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Pernille Gad, M.Sc. Novo Nordisk
Novo Nordisk
September 2011

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