Clinical Research Details

Descriptive Information
Efficacy and safety of liraglutide versus sulphonylurea both in combination with metformin during Ramadan in subjects with type 2 diabetes

Sami T Azar


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

  • Marwa Al Badri
  • Mira Zantout
  • Sara El Ghandour
  • NovoNordisk
Conditions and Keywords
Type 2 diabetes
Type 2 diabetes, ramadan fasting, Liraglutide, Sulphonylurea
Study Design
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
Open Label
Case Control
Eligibility and IRB
Min: 18



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.


  1.  hypersensitivity to trial products or related products.
  2.  Previous participation in this trial.
  3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
  4. Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator
  5. Participation in another clinical trial within 90 days prior to screening
  6. Any chronic disorder or severe disease which, in the opinion of the investigator might jeopardize subject’s safety or compliance with the protocol
  7. 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
  8. History of chronic pancreatitis or idiopathic acute pancreatitis
  9. Screening calcitonin value ≥ 50 ng/L
  10. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  11.  Impaired liver function, defined as ALAT ≥ 2.5 times upper normal limit (UNL)
  12.  Impaired renal function defined as eGFR < 60 mL/min/1.73 m2 per Modification of Diet in
    Renal Disease (MDRD) formula
  13.  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
  14. Heart failure, New York Heart Association (NYHA) class IV
  15. Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥100 mmHg)
  16. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  17. Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anesthesia, at the discretion of the investigator)
  18. Use of any drug (except for those stated in the inclusion criteria), which at the discretion of the investigator, could interfere with the blood glucose level (e.g., systemic corticosteroids)
  19. Known or suspected abuse of alcohol or drugs
  20. Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
  21.  Any contraindications to liraglutide