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Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®)

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ClinicalTrials.gov Identifier: NCT01680341
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : November 17, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):

August 31, 2012
September 7, 2012
October 16, 2015
November 17, 2015
March 17, 2017
August 2012
August 2013   (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 NCT01680341 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment
  • Subjects With HbA1c Below 7.0% [ Time Frame: Week 26 ]
    Number of subjects with HbA1c below 7% after 26 weeks of treatment.
  • Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia [ Time Frame: Week 26 ]
    Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-28 ]
    A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period [ Time Frame: From week 16 to end of trial including follow-up (week 27) ]
    Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 26 ]
  • Proportion of subjects with HbA1c below 7.0% [ Time Frame: Week 26 ]
  • Proportion of subjects with HbA1c below 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks [ Time Frame: Week 26 ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-28 ]
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period [ Time Frame: From week 16 to end of trial including follow-up (week 27) ]
  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
Not Provided
Not Provided
 
Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine
A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

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

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

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
    Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
    Other Name: IDegAsp
  • Drug: insulin degludec/insulin aspart
    Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
    Other Name: IDegAsp
  • Experimental: IDegAsp Simple
    Intervention: Drug: insulin degludec/insulin aspart
  • Experimental: IDegAsp Step wise
    Intervention: Drug: insulin degludec/insulin aspart

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
  • Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
  • Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
  • Life-threatening disease (e.g. cancer)
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
 
 
NCT01680341
NN5401-3941
2012-000373-23 ( EudraCT Number )
U1111-1127-4114 ( 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