NN1218-4131 Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes

The purpose of this trial is to confirm the efficacy and safety of faster-acting insulin aspart as mealtime insulin as well as postmeal injected insulin in combination with insulin degludec in subjects with T1DM. The results will be used in the registration file in Japan and label updates globally on use of faster aspart in combination with insulin degludec. In the European Medicines Agency (EMA) and FDA note for guidance on clinical investigation of
medicinal products for the treatment of diabetes, HbA1c is considered the most widely accepted
measure of overall, long-term glucose control. Consequently, HbA1c will be included as the primary endpoint18,19.
The trial is also intended to confirm that faster-acting insulin aspart, with its faster onset of action, is capable of demonstrating superior control of post prandial glycaemic excursion. In addition, this trial includes a postmeal faster-acting insulin aspart dosing arm in order to confirm that postmeal
administration could prove effective in achieving glucose control to offer a clinically acceptable
treatment option. There are instances when it is challenging for patients to dose bolus insulin before
a meal. Patients dose a rapid-acting insulin analogue after the start of a meal for reasons such as not being able to predict the volume of a meal that will be consumed (children, old people, sick days etc.), or if pre-meal dosing is not possible (including missed injections). Therefore it is considered
that there is a true clinical need for a rapid-acting insulin analogue product which can be administered after a meal.

Study phase: III

Study phase (if other): IIIb

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2. Male or female, age ? 18 years (for Japan and Taiwan: age ?20 years) at the time of signing informed consent
3. Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) ?12 months prior to screening
4. Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1)
5. Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1)
6. HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
7. Body Mass Index ? 35.0 kg/m2
8. Ability and willingness to adhere to the protocol including performing of self-measured plasma
glucose profiles and meal test
9. Ability and willingness to take at least three mealtime boluses a day every day during the trial
10. Not currently using real time continuous glucose monitoring system and/or willing not to use a real time continuous glucose monitoring system during the trial

Primary disease category: Diabetes & Endocrine System

Sponsor: Novo Nordisk.

Protocol number: NN1218-4131

Projected enrollment dates: February 2016 to November 2017

Official study title: NN1218-4131 Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes