Last updated on October 2015

Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus | Gastroparesis
  • Age: Between 40 - 80 Years
  • Gender: Male or Female
  • Other:
    Healthy subjects:
    Male or female (females using appropriate contraceptive method or willing to
    undergo pregnancy test)
    Body Mass Index (BMI) 19 - 30 kg/m2
    Type 2 Diabetic Patients:
    As per "healthy subjects"
    Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone
    or on metformin
    Glycated haemoglobin >6.0% and <8.5%

You may not be eligible for this study if the following are true:

  • Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal
    disease (severe in that the social or physical manifestations of the disease, or
    living with the condition, impact negatively and significantly on the individuals'
    ability to lead a normal day to day life), chronic alcohol abuse or epilepsy
    (excluded by history) or if iron status, or liver function tests are outside the
    following ranges:
    Alanine aminotransferase (ALT) 0 - 55 U/L
    Alkaline phosphatase 30 - 110 U/L
    Aspartate transaminase 0 - 45 U/L
    Amylase and/or lipase >3 x ULN
    Bilirubin 6 - 24 mmol/L
    Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
    Haemoglobin 115 - 155 g/L (females); 135 - 172 g/L (males)
    Subjects with a creatinine clearance cut-off of <50 ml/min
    Subjects requiring medication likely to influence blood pressure or gastrointestinal
    function
    Subjects with a past history of gastrointestinal disease, including known
    gastroparesis, significant upper gastrointestinal symptoms and previous gastric
    urgery
    Subjects with a past history of unexplained pancreatitis, chronic pancreatitis,
    pancreatectomy
    Subjects with a current or prior history of c-cell carcinoma
    Smoking > 10 cigarettes/day
    Alchohol consumption > 20 g/day
    Subjects who have donated blood in the previous 12 weeks
    Women of childbearing potential with no effective contraceptive method (defined as
    premenopausal, not surgically sterile women for at least 3 months prior to the time
    of screening) must have a confirmed negative urine B-hCG pregnancy test at screening
    visit. They must also use an effective contraceptive method throughout the study, and
    agree to repeat urine pregnancy test at designated visits.
    Lactation

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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