An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI 10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2 diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
BI 10773 tablets once daily high dose
1245.39.43001 Boehringer Ingelheim Investigational Site
Graz, Austria
1245.39.49002 Boehringer Ingelheim Investigational Site
Neuss, Germany
1245.39.39001 Boehringer Ingelheim Investigational Site
Pisa, Italy
Change From Baseline in Fasting Plasma Glucose at Day 1
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1
Time frame: Baseline and day 1
Change From Baseline in Fasting Plasma Glucose at Day 28
Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable
Time frame: Baseline and day 28
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28
Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1
Change from baseline in rate of endogenous glucose production (EGP) fast after one dose
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Time frame: Baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28
Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Time frame: Baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1
Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28
Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1
Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28
Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.
Time frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28