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
- 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
- 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
Liliana Uribe-Bruce, MD, MCI
Profil Institute for Clinical Research, Inc.