Completed

BOOST®Two Titration Algorithms for Insulin Degludec/Insulin Aspart in Type 2 Diabetes Mellitus

Study Aim

This phase 3 study aims to evaluate the effectiveness of two titration algorithms for Insulin Degludec/Insulin Aspart in managing Type 2 Diabetes Mellitus, specifically measuring the change in HbA1c levels after 26 weeks of treatment.

What is being tested

insulin degludec/insulin aspart

+ insulin degludec/insulin aspart

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: August 2012

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: April 2, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: August 31, 2012

Actual date on which the first participant was enrolled.

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.

NCT01680341

Principal SponsorNovo Nordisk A/S

Last updated: April 2, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

272 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate

Body mass index (BMI) below or equal to 40 kg/m^2

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

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)

5 exclusion criteria prevent from participating

Life-threatening disease (e.g. cancer)

Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator

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)

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 45 locations

Novo Nordisk Investigational Site

Goodyear, United StatesOpen Novo Nordisk Investigational Site in Google Maps

Novo Nordisk Investigational Site

Anaheim, United States

Novo Nordisk Investigational Site

Greenbrae, United States

Novo Nordisk Investigational Site

San Diego, United States

Completed45 Study Centers