Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 bas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2014
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT01850615
Start Date
September 23 2013
End Date
November 17 2014
Last Update
June 12 2019
Active Locations (58)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35211
2
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
3
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
4
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205