Expired Study
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Chula Vista, California


Purpose:

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


Study summary:

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


Criteria:

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


NCT ID:

NCT02367066


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Chula Vista, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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