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Clinical Trial Details

Trial ID: L3251
Source ID: NCT01611363
Associated Drug: Asp1941
Title: A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ASP1941|DRUG: Placebo
Outcome Measures: Primary: Part A: Assessment of glucose homeostasis in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin in healthy subjects and subjects with T2DM, 4 days|Part A: Assessment of peripheral glucose utilization after an oral glucose load, following multiple doses of ipragliflozin, 4 days|Part A: Assessment of splanchnic uptake after an oral glucose load, following multiple doses of ipragliflozin, 4 days|Part A: Assessment of mean glucose levels in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin, 4 days|Part B: Assessment of the relationship between the exposure to ipragliflozin in plasma, urinary glucose excretion and plasma glucose levels in subjects with T2DM, 6 days (PK), 12 days (urine) and 8 days (PD) | Secondary: Part A: Assessment of steady state urinary sodium excretion and urinary glucose excretion following multiple doses of ipragliflozin, 4 days (sodium) and 14 days (glucose) days|Part A: Assessment of energy production and utilization of energy sources following multiple doses of ipragliflozin, 4 days|Part A: Safety and tolerability following multiple doses of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia, Up to 21 days|Part B: Safety and tolerability following multiple doses of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia, Up to 21 days
Sponsor/Collaborators: Sponsor: Astellas Pharma Europe B.V.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-10-27
Completion Date: 2012-02-03
Results First Posted:
Last Update Posted: 2017-08-22
Locations: Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT01611363