A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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
Key facts
- Study ID
- NCT02367066
- Run by
- AstraZeneca
- People needed
- 30
- Starts
- 2015-03-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2016-06-23
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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