Diabetes Mellitus, Type 2 MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age ? 18 years - Subjects diagnosed with type 2 diabetes and treated with metformin ? 1500 mg/day (or maximum tolerated dose ? 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose - HbA1c 7.5% ? 9.5% (58 mmol/mol ? 80 mmol/mol) (both inclusive) - Body mass index ? 20 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 346 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject?s safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (? 7 days in total) with insulin in connection with intercurrent illness - Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice) - History of chronic pancreatitis or idiopathic acute pancreatitis - Screening calcitonin value ? 50 ng/L - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) - Impaired liver function, defined as alanine aminotransferase ? 2.5 times upper normal limit - Impaired renal function defined as estimated glomerular filtration rate < 60 mL/min/1.73 m^2 per modification of diet in renal disease formula - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening - Heart failure, New York Heart Association class IV - Uncontrolled treated or untreated hypertension (systolic blood pressure ?180 mmHg and/or diastolic blood pressure ?100 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of switch from sitagliptin 100 mg/day to liraglutide 1.8 mg/day, both + metformin vs. continued sitagliptin 100 mg/day + metformin on glycaemic control after 26 weeks of treatment in subjects with type 2 diabetes.;Secondary Objective: To compare the effect of switch from sitagliptin 100 mg/day to liraglutide 1.8 mg/day, both + metformin vs. continued sitagliptin 100 mg/day + metformin after 26 weeks of treatment in subjects with type 2 diabetes. - selected parameters of anthropometry - selected cardiovascular risk factors - safety and tolerability;Primary end point(s): Change in HbA1c This endpoint will be evaluated as the mean treatment difference.;Timepoint(s) of evaluation of this end point: From baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Confirmatory secondary endpoint 1. Change in body weight This endpoint will be evaluated as the mean treatment difference. Key supportive secondary endpoints Change in: 2. Fasting plasma glucose 3. Fasting blood lipids 4. Systolic blood pressure and diastolic blood pressure These endpoints will be evaluated as the mean treatment differences. Subjects who achieve (y/n): 5. HbA1c < 7.0% (53 mmol/mol) (American Diabetes Association target) This endpoint will be evaluated as the odds ratio between treatments. Safety endpoints 6. Number of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: Confirmatory secondary endpoint 1. - 4. From baseline to Week 26 5. After 26 weeks of treatment 6. During 26 weeks of treatment | — |
Countries
Canada, European Union, Hungary, India, Israel, Spain, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed