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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Faster-acting insulin aspart
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation 1<br> | Drug: Faster-acting insulin aspart<br>* Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.<br>* Other names: NN1218;|
| Experimental: Formulation 2<br> | Drug: Faster-acting insulin aspart<br>* Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.<br>* Other names: NN1218;|
| Active Comparator: Insulin aspart (NovoLog®)<br> | Drug: insulin aspart<br>* Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in plasma glucose concentration |  | From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-measured plasma glucose (SMPG) 7-point profile |  | After the first, the second, and the third 14-day treatment period | 
| Self-measured plasma glucose (SMPG) 9-point profile |  | After the first, the second, and the third 14-day treatment period | 
| Number of adverse events (AEs) (including infusion site reactions/infections) |  | Days 0-14 for each treatment periods | 
| Number of hypoglycaemic episodes |  | Days 0-14 for each treatment period | 
| Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) |  | Days 0-14 for each treatment period | 
| Number of episodes of infusion set occlusions |  | Days 0-14 for each treatment period |