Phase 4
Completed N=404
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01973231 ↗Enrolled (actual)
404
Serious AEs
4.7%
Results posted
Dec 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline — -1.809; -1.238 Percent (%) glycosylated haemoglobin
Summary
This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) From Baseline |
-1.809; -1.238 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline |
-2.904; -1.644 | — |
| SECONDARY Change in Body Weight From Baseline |
-4.24; -3.69 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) |
74.2; 45.5; 25.8; 54.5 | — |
| SECONDARY Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no) |
54.6; 26.2; 45.4; 73.8 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no) |
66.5; 41.9; 33.5; 58.1 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
540; 435; 13; 7; 10; 3 | — |
Eligibility 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
- 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% (53 mmol/mol - 91 mmol/mol) (both inclusive)
- Body Mass Index (BMI) equal to or above 20 kg/m^2
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 below 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 m^2 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)
Data sourced from ClinicalTrials.gov (NCT01973231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.