A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773

• Registration Number: NCT01248364
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Disposition First Submitted: 2014-04-28
• Disposition First Submitted QC: 2014-04-28
• Disposition First Posted: 2014-05-14
• Status Verified: 2014-08
• Results First Submitted: 2014-08-29
• Results First Submitted QC: 2014-08-29
• Last Update Submitted: 2014-08-29
• Results First Posted: 2014-09-09
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 10773 Arm	BI 10773	BI 10773 high dose once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Day 1	Baseline and day 1	Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1
Change From Baseline in Fasting Plasma Glucose at Day 28	Baseline and 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
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1	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 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.
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28	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 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1	Baseline and day 1	Change from baseline in rate of endogenous glucose production (EGP) fast after one dose
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28	Baseline and 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.
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1	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 the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28	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 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.
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1	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 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.
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28	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	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.

Trial Locations

Locations (3)

1245.39.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany

1245.39.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Graz, Austria

1245.39.39001 Boehringer Ingelheim Investigational Site; 🇮🇹 Pisa, Italy