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Clinical Trials/NCT01365507
NCT01365507CompletedPhase 3

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)

Novo Nordisk A/S1 site in 1 country276 target enrollmentStarted: June 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
276
Locations
1
Primary Endpoint
Change in Glycosylated Haemoglobin (HbA1c)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

IDegAsp Simple

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

IDegAsp Step wise

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, week 26

Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcomes

  • Change in Fasting Plasma Glucose (FPG)(Week 0, week 26)
  • Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 26 + 7 days follow up)
  • Rate of Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes(Week 0 to Week 26 + 7 days follow up)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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