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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: February 10, 2017
Last verified: February 2017
March 15, 2013
February 10, 2017
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 ]
Change from baseline in HbA1c after 26 weeks of treatment
Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
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 ]
    A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.
  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]

    Confirmed hypoglycaemic episodes were defined as episodes that are either:

    • severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or
    • biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]
    Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: During 26 weeks of treatment ]
  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]
  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/insulin aspart
    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: insulin degludec
    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: insulin degludec/insulin aspart
    • Drug: insulin aspart
  • Experimental: IDeg OD + IAsp TID
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin aspart
Bebakar WM, Chaykin L, Hersløv ML, Rasmussen S. Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal-Bolus): Exploratory Randomized Trial in Type 2 Diabetes. Diabetes Ther. 2017 Feb;8(1):197-205. doi: 10.1007/s13300-016-0213-8. Epub 2016 Nov 16.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Germany,   Malaysia,   Turkey,   United States
 
 
NCT01814137
NN5401-4003
2012-003152-37 ( EudraCT Number )
U1111-1132-2674 ( Other Identifier: WHO )
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
February 2017

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