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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin aspart

Drug: Faster-acting insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT01682902

NN1218-3930

U1111-1121-5106 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)