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 A/S
ClinicalTrials.gov Identifier:
NCT00978627
First received: September 16, 2009
Last updated: November 28, 2013
Last verified: November 2013

September 16, 2009
November 28, 2013
August 2009
May 2010   (final data collection date for primary outcome measure)
  • Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days of follow up ] [ Designated as safety issue: No ]
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00978627 on ClinicalTrials.gov Archive Site
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) after 52 weeks of treatment [ Time Frame: Week 0, Week 52 ] [ 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
NN5401-3594: 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 / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in 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 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

Main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec/insulin aspart
    Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
  • Drug: insulin detemir
    Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
  • Drug: insulin aspart
    Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
  • Drug: insulin aspart
    Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.
  • Experimental: IDegAsp OD
    Interventions:
    • Drug: insulin degludec/insulin aspart
    • Drug: insulin aspart
  • Active Comparator: IDet
    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
December 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • FOR THE MAIN TRIAL, NN5401-3594:
  • 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/m^2
  • FOR THE EXTENSION TRIAL, NN5401-3645:
  • The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

  • FOR THE MAIN TRIAL, NN5401-3594:
  • 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
  • FOR THE EXTENSION TRIAL, NN5401-3645:
  • Anticipated significant lifestyle changes during the trial
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Romania,   Poland,   Israel,   France,   Denmark,   Australia,   United Kingdom,   United States,   Puerto Rico
 
NCT00978627
NN5401-3594, 2008-005769-71, U1111-1111-8943, 2009-013412-13, U1111-1113-2475
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452), pgad, kit maria truelsen Novo Nordisk A/S
Novo Nordisk A/S
November 2013

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