Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Key facts

Study ID

NCT01850615

Run by

Novo Nordisk A/S

People needed

323

Starts

2013-09-23

Expected to finish

2014-11-17

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
• Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH 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 Dipeptidyl peptidase-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) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
• Body mass index (BMI) equal or less than 40.0 kg/m\^2

You may not qualify if…

• Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
• Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) 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)

Where it is running

• Novo Nordisk Investigational Site — Birmingham, Alabama, United States
• Novo Nordisk Investigational Site — Peoria, Arizona, United States
• Novo Nordisk Investigational Site — Little Rock, Arkansas, United States
• Novo Nordisk Investigational Site — Santa Ana, California, United States
• Novo Nordisk Investigational Site — Tarzana, California, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Clearwater, Florida, United States
• Novo Nordisk Investigational Site — Pembroke Pines, Florida, United States
• Novo Nordisk Investigational Site — Conyers, Georgia, United States
• Novo Nordisk Investigational Site — New Orleans, Louisiana, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Kalamazoo, Michigan, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Henderson, Nevada, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States
• Novo Nordisk Investigational Site — Brooklyn, New York, United States
• Novo Nordisk Investigational Site — Asheboro, North Carolina, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Oklahoma City, Oklahoma, United States
• Novo Nordisk Investigational Site — Downingtown, Pennsylvania, United States
• Novo Nordisk Investigational Site — Reading, Pennsylvania, United States
• Novo Nordisk Investigational Site — Greenville, South Carolina, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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