Clinical trial NCT01682902: A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Official title: A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean change in plasma glucose concentration
timeFrame: From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period
Secondary outcomes:
measure: Self-measured plasma glucose (SMPG) 7-point profile
timeFrame: After the first, the second, and the third 14-day treatment period
measure: Self-measured plasma glucose (SMPG) 9-point profile
timeFrame: After the first, the second, and the third 14-day treatment period
measure: Number of adverse events (AEs) (including infusion site reactions/infections)
timeFrame: Days 0-14 for each treatment periods
measure: Number of hypoglycaemic episodes
timeFrame: Days 0-14 for each treatment period
measure: Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)
timeFrame: Days 0-14 for each treatment period
measure: Number of episodes of infusion set occlusions
timeFrame: Days 0-14 for each treatment period
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.