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 enrollmentJune 2011

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/insulin aspart

Drugsinsulin degludec/insulin aspart

Overview

Phase: Phase 3
Intervention: insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 276
Locations: 1
Primary Endpoint: Change in Glycosylated Haemoglobin (HbA1c)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

April 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

IDegAsp Simple

Intervention: insulin degludec/insulin aspart

IDegAsp Step wise

Intervention: insulin degludec/insulin aspart

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)