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Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens (BOOST™)

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ClinicalTrials.gov Identifier: NCT01365507
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : November 20, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDegAsp Simple Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Name: IDegAsp
Experimental: IDegAsp Step wise Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Name: IDegAsp


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment.

  2. Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

  3. Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as 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.

  4. Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as 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 a.m.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
  • Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
  • Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
  • BMI (Body Mass Index) below or equal to 45 kg/m^2
  • Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Exclusion Criteria:

  • Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
  • Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
  • Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365507


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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01365507     History of Changes
Other Study ID Numbers: NN5401-3844
U1111-1117-0558 ( Other Identifier: WHO )
First Posted: June 3, 2011    Key Record Dates
Results First Posted: November 20, 2015
Last Update Posted: March 17, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
 Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs