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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
30
Oral dose of AR-C165395XX (tablets)
Oral dose of placebo for AR-C165395XX (tablets)
Research Site
Chula Vista, California, United States
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
GGI=Glucose and GLP1 infusion AUC=Area Under Curve
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon
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Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint Fasting Beta-cell Responsiveness
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Fasting Insulin at Endpoint
Time frame: Day 3 and Day 9
Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max
Time frame: Days 2,3,8,9
Time of Maximum Plasma AZD1081 Concentration, t_ss,Max
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-1h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-2h)
Time frame: Days 2,3,8,9
Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(1-2h)
Time frame: Days 2,3,8,9
Plasma Paracetamol Maximum Concentration, C_max
Time frame: Days 3,9
Time of Maximum Plasma Paracetamol Concentration, t_max
Time frame: Days 3,9
Plasma Paracetamol AUC(0-t)
Time frame: Days 3,9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Plasma AZD1981 AUC(0-4h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-12h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-24h)
Time frame: Days 2,3,8,9
Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F
Time frame: Days 2,3,8,9