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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558571
• Other study ID #: 1245.4
• Secondary ID: EudraCT No 2007-
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2007
• Last updated: July 16, 2014
• Start date: January 2008

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• BI 10773 low dose

• placebo to BI 10773

• BI 10773 medium dose

• BI 10773 high dose

Locations

Country	Name	City	State
Germany	1245.4.49003 Boehringer Ingelheim Investigational Site	Berlin
Germany	1245.4.49002 Boehringer Ingelheim Investigational Site	Mainz
Germany	1245.4.49001 Boehringer Ingelheim Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Drug Related Adverse Events	number of subjects with investigator-defined drug-related adverse events.	from drug administration up to 6 weeks	No
Primary	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG	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.	from drug administration up to 6 weeks	No
Secondary	Cmax of Empagliflozin	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).	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	No
Secondary	Tmax of Empagliflozin	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.	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	No
Secondary	t1/2 of Empagliflozin	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.	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	No
Secondary	AUC0-8 of Empagliflozin	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8) and over a uniform dosing interval t at steady state (AUCt,ss)	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	No
Secondary	CL/F of Empaglifozin	apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)	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	No
Secondary	fe0-24 of Empagliflozin	Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)	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	No
Secondary	LI (Linearity Index).	The linearity index is defined as AUC0-t divided by AUC0-8 both at steady state.	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	No
Secondary	Ae0-24 of Glucose	Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)	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	No
Secondary	Fasting Plasma Glucose (FPG)	fasting plasma glucose on day -1 (baseline) and change from baseline to day 28	in the morning of days -1 and 28	No
Secondary	Mean Daily Glucose (MDG) Measured in Blood	change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.	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	No
Secondary	Insulin AUEC0-5	change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.	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.	No
Secondary	Insulin Emax (Maximum Measured Effect)	change in Emax from baseline on day 28. Baseline is defined as day -1	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.	No
Secondary	Fasting Insulin	Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.	in the morning of days -1( baseline), 1, 7, 14, 21 and 28	No
Secondary	Glucagon Emax (Maximum Measured Effect)	Change from baseline (day -1) in Emax on day 28.	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.	No
Secondary	Glucagon AUEC0-5	Change from baseline (day -1) in AUEC0-5 on day 28.	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.	No
Secondary	Fructosamine	change from baseline to days 14 and 18. Baseline is defined as day -1.	day -1 (baseline), 14 and 28	No
Secondary	HbA1c	change from baseline on day 28. Baseline is defined as day -1.	in the morning of days -1 and 28	No

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