A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2012
End Date:March 2013
Contact:Novo Nordisk Clinical Trial Call Center
Phone:866-867-7178

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


This trial is conducted in the United States of America (USA). The aim of the trial is to
evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects
with type 1 diabetes.


Inclusion Criteria:

- Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the
screening visit (Visit 1)

- Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin
infusion) for the previous 3 months prior to the screening visit (Visit 1)

- Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6
months prior to the screening visit (Visit 1)

- Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory

- Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Exclusion Criteria:

- History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6
months prior to the screening visit (Visit 1)

- History of abscess at the infusion site within 6 months prior to the screening visit
(Visit 1)

- Hypoglycaemic unawareness as judged by the Investigator or history of severe
hypoglycaemic episodes requiring hospitalization within the last 6 months prior to
the screening visit (Visit 1)
We found this trial at
1
site
?
mi
from
Atlanta, GA
Click here to add this to my saved trials