A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AR-C165395XX + placebo

1st period AR-C165395XX 2nd period placebo

Group Type EXPERIMENTAL

AR-C165395XX

Intervention Type DRUG

Oral dose of AR-C165395XX (tablets)

Placebo + AR-C165395XX

1st period Placebo for AR-C165395XX 2nd period AR-C165395XX

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral dose of placebo for AR-C165395XX (tablets)

Interventions

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AR-C165395XX

Oral dose of AR-C165395XX (tablets)

Intervention Type DRUG

Placebo

Oral dose of placebo for AR-C165395XX (tablets)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No