Overview

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

Status:
Completed

Trial end date:
2017-08-16

Target enrollment:
0

Participant gender:
All

Summary

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Treatments:

Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting

Criteria

Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and
Taiwan: age greater than or equal to 20 years) at the time of signing informed consent -
Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory
analysis as per local guidelines) 12 months or more prior to screening - Currently treated
with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) -
Currently treated with a basal insulin analogue for at least 4 months prior to screening
(Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central
laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within
the past 180 days any of the following: myocardial infarction, stroke or hospitalization
for unstable angina and/or transient ischemic attack - Subjects presently classified as
being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or
peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation
within the last 180 days prior to screening (Visit 1) - Treatment with any medication for
the indication of diabetes or obesity other than stated in the inclusion criteria in a
period of three months before screening (Visit 1)