A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated
 Doses for 3 days in Subjects with Type 2 Diabetes Mellitus
A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to
 Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3
 days in Subjects with Type 2 Diabetes Mellitus
Inclusion Criteria

 -  Provision of informed consent

 -  Male or female of non-childbearing potential (postmenopausal, and/or have undergone
 hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.

 -  Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)

 -  ody mass index >19 to <38 kg/m2

 -  he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL,
 nclusive) on the morning of Visit 1.

 -  Clinical diagnosis of type 2 diabetes mellitus

 -  Metformin as only anti-diabetic treatment, at least for the last 3 months

 Exclusion Criteria:

 -  History or sign of any clinically significant disease or disorder which, in the
 opinion f the investigator, may either put the subject at risk because of
 participation in the sudy, or influence the results or the subject's ability to
 participate in the study

 -  Any clinically significant abnormalities in clinical chemistry, haematology or
 urinalysis results as judged by the investigator

 -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results
 >3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus
 and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase
 Autoantibodies test (GAD antibodies test).

 -  Patients treated with single Insulin therapy within the last 3 months