A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01814137
First received: March 15, 2013
Last updated: March 11, 2014
Last verified: March 2014

March 15, 2013
March 11, 2014
March 2013
March 2014   (final data collection date for primary outcome measure)
Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01814137 on ClinicalTrials.gov Archive Site
  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

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 2
  • Drug: IDegAsp
    For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
  • Drug: IDeg
    For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
  • Drug: insulin aspart

    For subcutaneous (s.c., under the skin) administration once daily.

    Dose of IDegAsp and IAsp are individually adjusted.

  • Drug: insulin aspart

    For subcutaneous (s.c., under the skin) administration three times a day.

    Dose of IDeg and IAsp are individually adjusted.

  • Experimental: IDegAsp BID + IAsp OD
    Interventions:
    • Drug: IDegAsp
    • Drug: insulin aspart
  • Experimental: IDeg OD + IAsp TID
    Interventions:
    • Drug: IDeg
    • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

Exclusion Criteria:

  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
  • Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
  • Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Malaysia,   Germany,   Turkey,   United States
 
NCT01814137
NN5401-4003, 2012-003152-37, U1111-1132-2674
No
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
March 2014

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