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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:April 2012

Use our guide to learn which trials are right for you!

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)

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.


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
We found this trial at
24
sites
Palm Springs, California 92262
?
mi
from
Palm Springs, CA
Click here to add this to my saved trials
Asheboro, North Carolina 27203
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
Chino, California 91710
?
mi
from
Chino, CA
Click here to add this to my saved trials
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Eagan, MN
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hyattsville, Maryland 20782
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madisonville, Kentucky 42431
?
mi
from
Madisonville, KY
Click here to add this to my saved trials
Milwaukee, Wisconsin 53209
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
North East, Maryland 21901
?
mi
from
North East, MD
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Paducah, Kentucky 42003
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Pembroke Pines, Florida 33027
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Seoul,
Click here to add this to my saved trials
Smithtown, New York 11787
?
mi
from
Smithtown, NY
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
?
mi
from
Sugarland, TX
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials