Skip Ribbon Commands
Skip to main content

UCHealth Home

:

Clinical Trials: Novo Nordisk NN1218-3853 - FIAsp: Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination with Insulin Glargine and Metformin in Adults with Type 2 Diabetes

 


Novo Nordisk NN1218-3853 - FIAsp: Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination with Insulin Glargine and Metformin in Adults with Type 2 Diabetes


Trial Focus

Trial Focus

Diabetes

Objective

        

Trial Status

Accepting Participants

Contact

Brad Wine at 720-848-5596 or bradley.wine@ucdenver.edu

Location

University of Colorado HospitalUniversity of Colorado Hospital

Eligibility and Other Participant Information


Inclusion criteria
1.Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)
2.Treated with basal insulin for at least 6 months prior to screening (visit 1)
3.Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
4.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 (dipeptidyl peptidase-4) 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
5.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 (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)
6.Body mass index (BMI) equal to or below 40.0 kg/m^2
Exclusion criteria
1.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)
2.Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1)
3.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)
4.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