Diabetes Mellitus, Type 2 MedDRA version: 16.1 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 - Males and females age 18 years or older - Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening - HbA1c 7.5- 10.5% (58 mmol/mol - 91 mmol/mol) (both inclusive) - Body mass index (BMI) equal to or above 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 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice) - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness - History of chronic pancreatitis or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 per Modification of Diet in Renal Disease (MDRD) formula - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening - Heart failure, New York Heart Association (NYHA) class IV - Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg) - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of liraglutide versus lixisenatide as add-on to metformin on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes mellitus (T2DM);Secondary Objective: To compare the effect of liraglutide versus lixisenatide as add-on to metformin after 26 weeks of treatment in subjects with T2DM on: - beta-cell function - other parameters of efficacy, safety and tolerability;Primary end point(s): Change in glycosylated haemoglobin (HbA1c) ;Timepoint(s) of evaluation of this end point: From baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoints 1. Change in fasting plasma glucose (FPG) 2. Change in body weight These endpoints will be evaluated as the mean treatment differences. 3. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no) 4. Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) (yes/no) 5. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain (yes/no) These endpoints will be evaluated as the odds ratio between treatments. Key safety endpoint 6. Number of treatment emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline to week 26 3. + 4. + 5. After 26 weeks of treatment 6. During 26 weeks of treatment | — |
Countries
Czech Republic, Finland, Germany, Hungary, Latvia, Lithuania, United Kingdom
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed