Efficacy and Safety of FIAsp compared to insulin aspart both in Combination with insulin detemir in Adults with Type 1 Diabetes

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-024049-53-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-30
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1095

Inclusion Criteria

• Female or male, age 18 years or older at the time of screening (Visit 1)
• 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) equal to or below 35.0 kg/m^2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 602
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 493

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified