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Clinical Trial Details

Trial ID: L1802
Source ID: NCT02367066
Associated Drug: Ar-C165395xx
Title: A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02367066/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: AR-C165395XX|OTHER: Placebo
Outcome Measures: Primary: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose, MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint MMTT C_max for Plasma Glucose, 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, Day -1 to Day 3 and Day 6 to Day 9 | Secondary: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint Fasting Beta-cell Responsiveness, Day -1 to Day 3 and Day 6 to Day 9|Fasting Insulin at Endpoint, Day 3 and Day 9|Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max, Days 2,3,8,9|Time of Maximum Plasma AZD1081 Concentration, t_ss,Max, Days 2,3,8,9|Plasma AZD1981 AUC(0-1h), Days 2,3,8,9|Plasma AZD1981 AUC(0-2h), Days 2,3,8,9|Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min, Days 2,3,8,9|Plasma AZD1981 AUC(1-2h), Days 2,3,8,9|Plasma Paracetamol Maximum Concentration, C_max, Days 3,9|Time of Maximum Plasma Paracetamol Concentration, t_max, Days 3,9|Plasma Paracetamol AUC(0-t), Days 3,9|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide, Day -1 to Day 3 and Day 6 to Day 9|Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose, Day -1 to Day 3 and Day 6 to Day 9|Plasma AZD1981 AUC(0-4h), Days 2,3,8,9|Plasma AZD1981 AUC(0-12h), Days 2,3,8,9|Plasma AZD1981 AUC(0-24h), Days 2,3,8,9|Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F, Days 2,3,8,9
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-03
Completion Date: 2015-05
Results First Posted: 2016-06-23
Last Update Posted: 2016-06-23
Locations: Research Site, Chula Vista, California, United States
URL: https://clinicaltrials.gov/show/NCT02367066