Type 2 diabetes, ramadan fasting, Liraglutide, Sulphonylurea
Other: Describe in Detailed Description
The primary objective of the study is to compare the effect of liraglutide versus the antidiabetic class of sulphonylurea both in combination with metformin on change in glycemic control during the month of Ramadan.
Safety and/or Efficacy Study
Eligibility and IRB
Written informed consent, type 2 diabetes, male and female > 18 years,treated with metformin ≥ 1000 mg/day and sulphonylurea at maximum tolerated dose (at least half of the 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.
HbA1c 7.0 % -10.0% inclusive.BMI ≥ 20 kg/m2.
Willing to fast Ramadan and give blood during Ramadan.
hypersensitivity to trial products or related products.
Previous participation in this trial.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator
Participation in another clinical trial within 90 days prior to screening
Any chronic disorder or severe disease which, in the opinion of the investigator might jeopardize 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 inter-current illness
History of chronic pancreatitis or idiopathic acute pancreatitis
Screening calcitonin value ≥ 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 ALAT ≥ 2.5 times upper normal limit (UNL)
Impaired renal function defined as eGFR < 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