Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination with Insulin Glargine and Metformin in Adults with Type 2 Diabetes

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; Diabetes Mellitus, Type 2; MedDRA version: 16.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861

• Registration Number: EUCTR2010-024051-93-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

• Female or male, age = 18 years at the time of signing inform consent
• Type 2 diabetes (diagnosed clinically) = 6 months at time of screening (visit 1)
• Treated with basal insulin for at least 6 months prior to screening (visit 1)
• Current once daily treatment with insulin NPH, insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
• Current treatment with:
a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
or
b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
• HbA1c by central laboratory:
a. 7.0 - 9.5% (53 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1)
or
b. 7.0 - 9.0% (53 – 75 mmol/mol) (both inclusive) in the metformin + other OAD (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)
• Body mass index (BMI) = 40.0 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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 276

Exclusion Criteria

• Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1)
• Use of GLP-1 agonists and/or TZDs within the last 3 months prior to screening (visit 1)
• Recurrent severe hypoglycaemia (more than 1 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 or coronary arterial bypass graft or angioplasty

Study & Design

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