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 |
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)
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