Status:
COMPLETED
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2015
Estimated Enrollment :
1290 Patients enrolled
Trial Details
Trial ID
NCT01831765
Start Date
August 26 2013
End Date
June 11 2015
Last Update
June 12 2019
Active Locations (191)
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1
Novo Nordisk Investigational Site
Mobile, Alabama, United States, 36608
2
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85714
3
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85724
4
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801