A trial to evaluate the efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin during Ramadan in Subjects With Type 2 Diabetes
- Conditions
- Health Condition 1: null- â?¢Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2014/03/004499
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
•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/m2
•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
18 Years and older
•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 subjects 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 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
•Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in fructosamine from start of Ramadan to end of RamadanTimepoint: Day -1, day 29
- Secondary Outcome Measures
Name Time Method .Change from baseline to end of Ramadan in FPG <br/ ><br>.Change from baseline to end of Ramadan in glycosylated haemoglobin <br/ ><br>.Change from baseline to end of Ramadan in body weight <br/ ><br>Timepoint: Baseline, day 29;.Change from start of Ramadan to end of Ramadan in fasting plasma glucose <br/ ><br>.Number of confirmed hypoglycaemic episodes <br/ ><br>.Number of treatment emergent adverse events <br/ ><br>Timepoint: Day -1 to day 29;.Fructosamine at end of Ramadan <br/ ><br>.Subjects who at end of treatment (4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol), and no confirmed hypoglycaemic episodes <br/ ><br>.Subjects who at end of treatment (4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0%Timepoint: Day 29