Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; metformin; sulphonylurea
Intervention description: 1.8 mg administered subcutaneously (s.c., under the skin) once daily; Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged; Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
Intervention MeSH terms: Metformin; Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa and Asia. The aim of the trial is to investigate the
      efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with
      metformin during Ramadan in subjects with type 2 diabetes (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Subjects diagnosed with T2DM and treated with metformin equal to or above 1000
             mg/day and SU (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated
             dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose
             (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening.
             Stable is defined as unchanged medication and dose

          -  - HbA1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)

          -  - Body Mass Index (BMI) equal to or above 20 kg/m^2

          -  - Subjects who have expressed their intention to fast (daytime, i.e. between sunrise
             and sunset) during Ramadan after receiving medical counselling regarding the risk of
             fasting

        Exclusion Criteria:

          -  - Any contraindication for successful and sustained fasting from a medical perspective
             at the discretion of the investigator (such as acute illness, severe hypoglycaemia
             within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia
             unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar
             hyperglycaemic coma within 90 days prior to screening, subjects performing intense
             physical labour)

          -  - Any chronic disorder or severe disease which, in the opinion of the investigator
             might jeopardise subject's safety or compliance with the protocol

          -  - 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

          -  - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin
             cancer or squamous cell skin cancer)