Overview

Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

Status:
Completed
Trial end date:
2015-06-11
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin Detemir
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the
time of screening (Visit 1) - 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 (any regimen of insulin detemir or insulin glargine) 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 (BMI) below or equal to 35.0 kg/m^2 Exclusion
Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior
to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic
event during the last 12 months) or hypoglycaemic unawareness as judged by the
Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months
prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to
screening (Visit 1), defined as stroke, decompensated heart failure New York Heart
Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris,
coronary arterial bypass graft or angioplasty