4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo (middle dose); Drug: BI 10773; Drug: Placebo; Drug: Placebo (high dose); Drug: Placebo (low dose)

• Registration Number: NCT00885118
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2009-10
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Results First Posted: 2014-06-16
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 mid-low dose QD	Placebo (middle dose)	patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
BI 10773 high dose QD	Placebo (high dose)	patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
BI 10773 low dose quaque die (QD)	Placebo (low dose)	patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
BI 10773 low dose quaque die (QD)	BI 10773	patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
BI 10773 high dose QD	BI 10773	patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
Placebo	Placebo	patient to receive two tablets of placebo once daily
BI 10773 mid-low dose QD	BI 10773	patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
BI 10773 mid-high dose QD	BI 10773	patient to receive two tablets of BI 10773 middle dose once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Urine Glucose Excretion	baseline and 28 days	Change from baseline in Urine glucose excretion to 28 days
Change From Baseline in 8-point Glucose	baseline and 27 days	Change from baseline in 8-point glucose to 27 days
Change From Baseline in Fasting Plasma Glucose	baseline and 28 days	Change from baseline in Fasting plasma glucose to 28 days

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c	baseline and 28 days	Change from baseline in HbA1c to 28 days
CL/F	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	apparent clearance of the analyte in plasma after extravascular administration
Vz/F	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	apparent volume of distribution during the terminal phase λz following an extravascular dose
Change From Baseline in Fructosamine	baseline and 28 days	Change from baseline in Fructosamine to 28 days
Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)	baseline and 28 days	Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days
Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)	baseline and 28 days	Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days
fe0-24	0-5, 5-12, 12-24 hour after first drug administration	fraction of the analyte excreted unchanged in urine from time interval 0 to 24
Cmax,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration	maximum measured concentration of the analyte in plasma at steady state
CLR,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration	renal clearance of the analyte at steady state determined over the dosing interval τ
Change From Baseline in 1,5-anhydroglucitol	baseline and 28 days	Change from baseline in 1,5-anhydroglucitol to 28 days
Change From Baseline in Fasting Insulin	baseline and 28 days	Change from baseline in Fasting insulin to 28 days
t1/2	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	terminal half-life of the analyte in plasma
Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)	baseline and 28 days	Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days
AUCτ,1	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ
AUC0-tz	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration
AUC0-∞	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Cmax	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration	maximum measured concentration of the analyte in plasma
Ae0-24	0-5, 5-12, 12-24 hour after first drug administration	amount of the analyte that is eliminated in urine over the time interval 0 to 24
CLR,0-24	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration	renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data
RA,Cmax	Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration	accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax
AUCτ,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration	area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state
t1/2,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration	terminal half-life of the analyte in plasma at steady state
CL/F,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration	apparent clearance of the analyte in plasma after extravascular administration at steady state
Vz/F,ss	Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration	apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state
RA,AUC	Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration	accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ
Ae0-24,ss	0-5, 5-12, 12-24 hour after last drug administration	amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24
fe0-24,ss	0-5, 5-12, 12-24 hour after last drug administration	fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24

Trial Locations

Locations (5)

1245.15.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Hachioji, Tokyo, Japan

1245.15.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Koganei, Tokyo, Japan

1245.15.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1245.15.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Nakano-ku, Tokyo, Japan

1245.15.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan