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

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005583-10-SI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-16
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Age =18 years at time the informed consent is signed by the Subject (Visit 1)
• Type 2 diabetes (diagnosed clinically) = 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 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 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• Any use of bolus insulin, except short-term use due to intermittent illness (no longer than14 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)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm superiority of meal-time Faster-acting insulin aspart (FIAsp) in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of glycaemic control after 18-weeks of randomised treatment;Secondary Objective: • To compare meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of postprandial glucose (PPG) regulation after 18 weeks of randomised treatment<br>• To compare other efficacy and safety endpoints of meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, after 18 weeks of randomised treatment<br>;Primary end point(s): • Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 18 weeks of randomised treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Self-measured plasma glucose (SMPG) 7- point profile<br>a. Post prandial plasma glucose (PPG), overall 2-hour mean (of breakfast, lunch, main evening meal)<br>b. Prandial plasma glucose (PG) increment, overall 2-hour mean (of breakfast, lunch, main evening meal)<br>2. Change from baseline in body weight <br>3. Number of treatment emergent hypoglycaemic episodes <br>4. Number of adverse events ;Timepoint(s) of evaluation of this end point: 1.-2. After 18 weeks of randomised treatment<br>3.-4. During 18 weeks of randomised treatment<br><br>