Clinical trial NCT00558571: 4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 %

Primary outcomes:
measure: Number of Subjects With Drug Related Adverse Events
timeFrame: from drug administration up to 6 weeks
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
timeFrame: from drug administration up to 6 weeks
Secondary outcomes:
measure: Cmax of Empagliflozin
timeFrame: 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
measure: Tmax of Empagliflozin
timeFrame: 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
measure: t1/2 of Empagliflozin
timeFrame: 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
measure: AUC0-∞ of Empagliflozin
timeFrame: 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
measure: CL/F of Empaglifozin
timeFrame: 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
measure: fe0-24 of Empagliflozin
timeFrame: 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
measure: LI (Linearity Index).
timeFrame: 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
measure: Ae0-24 of Glucose
timeFrame: 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
measure: Fasting Plasma Glucose (FPG)
timeFrame: in the morning of days -1 and 28
measure: Mean Daily Glucose (MDG) Measured in Blood
timeFrame: 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
measure: Insulin AUEC0-5
timeFrame: 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.
measure: Insulin Emax (Maximum Measured Effect)
timeFrame: 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.
measure: Fasting Insulin
timeFrame: in the morning of days -1( baseline), 1, 7, 14, 21 and 28
measure: Glucagon Emax (Maximum Measured Effect)
timeFrame: 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.
measure: Glucagon AUEC0-5
timeFrame: 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.
measure: Fructosamine
timeFrame: day -1 (baseline), 14 and 28
measure: HbA1c
timeFrame: in the morning of days -1 and 28
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1245.4.49003 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1245.4.49002 Boehringer Ingelheim Investigational Site
city: Neuss
country: Germany
facility: 1245.4.49001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
citation: Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.