Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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

- 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- beta-cell function<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary efficacy endpoints<br>1. Change in fasting plasma glucose (FPG)<br>2. Change in body weight<br>These endpoints will be evaluated as the mean treatment differences.<br><br>3. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no)<br>4. Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) (yes/no)<br>5. Subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain (yes/no)<br>These endpoints will be evaluated as the odds ratio between treatments.<br><br>Key safety endpoint<br>6. Number of treatment emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline to week 26<br>3. + 4. + 5. After 26 weeks of treatment<br>6. During 26 weeks of treatment

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