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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 | Clinical Trials | Clareo Health

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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

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)

NCT01680341•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

Locations (45)

Novo Nordisk Investigational Site

Goodyear, Arizona, United States

Novo Nordisk Investigational Site

Anaheim, California, United States

Novo Nordisk Investigational Site

Greenbrae, California, United States

Novo Nordisk Investigational Site

San Diego, California, United States

Novo Nordisk Investigational Site

Spring Valley, California, United States

Novo Nordisk Investigational Site

Bradenton, Florida, United States

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Novo Nordisk Investigational Site

Plantation, Florida, United States

Novo Nordisk Investigational Site

St. Petersburg, Florida, United States

Novo Nordisk Investigational Site

Suwanee, Georgia, United States

Key Dates

Start Date

August 31, 2012

Primary Completion Date

August 22, 2013

Completion Date

August 22, 2013

Last Updated

April 2, 2018

Enrollment

272

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspart

DRUG

insulin degludec/insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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