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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Placebo; Drug: AR-C165395XX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02367066

D6420C00001

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

AR-C165395XX + placebo

Experimental group

Description:

1st period AR-C165395XX 2nd period placebo

Treatment:

Drug: AR-C165395XX

Placebo + AR-C165395XX

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo