4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773 high dose; Drug: BI 10773 low dose; Drug: placebo to BI 10773; Drug: BI 10773 medium dose

• Registration Number: NCT00558571
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Study Start: 2008-01
• Primary Completion: 2008-04
• Results First Submitted: 2014-05-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-16
• Last Update Submitted: 2014-07-16
• Results First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Male and postmenopausal or hysterectomised female patients with type 2 diabetes
• Age >18 and < 70 years
• BMI >18.5 and <40 kg/m2

Exclusion Criteria

• Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
• Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
• HbA1c > 8.5 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 high dose	BI 10773 high dose	-
BI 10773 low dose	BI 10773 low dose	-
Placebo	placebo to BI 10773	-
BI 10773 medium dose	BI 10773 medium dose	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Drug Related Adverse Events	from drug administration up to 6 weeks	number of subjects with investigator-defined drug-related adverse events.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG	from drug administration up to 6 weeks	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Secondary Outcome Measures

Name	Time	Method
AUC0-∞ of Empagliflozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)
Fasting Plasma Glucose (FPG)	in the morning of days -1 and 28	fasting plasma glucose on day -1 (baseline) and change from baseline to day 28
Cmax of Empagliflozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28	maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).
CL/F of Empaglifozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28	apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)
Tmax of Empagliflozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28	time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.
Ae0-24 of Glucose	Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h	Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)
Insulin Emax (Maximum Measured Effect)	0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.	change in Emax from baseline on day 28. Baseline is defined as day -1
Glucagon Emax (Maximum Measured Effect)	0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.	Change from baseline (day -1) in Emax on day 28.
t1/2 of Empagliflozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28	terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.
LI (Linearity Index).	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28	The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.
fe0-24 of Empagliflozin	0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28	Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)
Mean Daily Glucose (MDG) Measured in Blood	0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27	change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.
Insulin AUEC0-5	0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.	change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.
Fasting Insulin	in the morning of days -1( baseline), 1, 7, 14, 21 and 28	Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.
Glucagon AUEC0-5	0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.	Change from baseline (day -1) in AUEC0-5 on day 28.
Fructosamine	day -1 (baseline), 14 and 28	change from baseline to days 14 and 18. Baseline is defined as day -1.
HbA1c	in the morning of days -1 and 28	change from baseline on day 28. Baseline is defined as day -1.

Trial Locations

Locations (3)

1245.4.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany

1245.4.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany

1245.4.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany