type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject) 2.Subjects (male or female) diagnosed with type 2 diabetes 3.Stable metformin monotherapy of =1500 mg daily for at least three months prior to screening. Short-term change of metformin dose in connection with intercurrent illness within three months prior to enrolment into the trial is allowed, at the discretion of the Investigator 4.HbA1c 7.5-10.0% (both inclusive) 5.Age 18-80 years, both inclusive (or as allowed according to local guidelines for metformin treatment) 6.BMI = 45.0 (weight [kg]/height^2 [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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator) or glucagon like peptide-1 (GLP-1) receptor agonists (including liraglutide or exenatide) or dipeptidyl peptidase 4 (DPP-4) inhibitors •Treatment with hypoglycaemic agent(s) other than metformin within the last three months prior to the trial •Impaired liver and renal function •Known clinically significant active cardiovascular disease or uncontrolled treated/untreated hypertension •Known proliferative retinopathy or maculopathy requiring acute treatment •Recurrent major hypoglycaemia or hypoglycaemic unawareness •Present or anticipated use of any drug which could interfere with glucose levels (e.g. systemic corticosteroids) •Any contraindications or other restrictions to metformin or sitagliptin according to the local labelling •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant •Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the Investigator’s opinion could interfere with the results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare the efficacy (as assessed by change from baseline in HbA1c) after 26 weeks of adding liraglutide versus sitagliptin to the pre-trial metformin treatment in subjects with type 2 diabetes inadequately controlled on metformin.;Secondary Objective: To assess and compare the effect on: •other parameters of glycaemic control •ß-cell function (incl. using homeostasis model assessment (HOMA) ) •fasting lipid profile •cardiovascular biomarkers •body weight •waist circumference and waist to hip ratio •blood pressure ;Primary end point(s): • HbA1c | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom
Outcome results
None listed