In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma glucose in T2DM subjects will be investigated.
This study will consist of 2 parts. In Part A the effect of ipragliflozin on the glucose homeostasis will be investigated and in Part B we will investigate the effect of exposure of ipragliflozin on UGE and plasma glucose levels. Part A This part will be a randomized, double-blind, placebo-controlled, 2- period, 2 treatment crossover design in healthy subjects and in T2DM subjects who are drug naïve or washed out for metformin prior to admission to the clinical site. Part B This part will be an open-label, randomized, 2-period, 2 treatment crossover design in T2DM subjects stratified by baseline HbA1c levels (6.0-6.9%, 7.0-7.9%, 8.0-8.9% or 9.0-9.9%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
44
Unnamed facility
Neuss, Germany
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
Time frame: 4 days
Part A: Assessment of peripheral glucose utilization after an oral glucose load, following multiple doses of ipragliflozin
Time frame: 4 days
Part A: Assessment of splanchnic uptake after an oral glucose load, following multiple doses of ipragliflozin
Time frame: 4 days
Part A: Assessment of mean glucose levels in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin
Time frame: 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
Time frame: 6 days (PK), 12 days (urine) and 8 days (PD)
Part A: Assessment of steady state urinary sodium excretion and urinary glucose excretion following multiple doses of ipragliflozin
Time frame: 4 days (sodium) and 14 days (glucose) days
Part A: Assessment of energy production and utilization of energy sources following multiple doses of ipragliflozin
Time frame: 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
Time frame: Up to 21 days
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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
Time frame: Up to 21 days