Skip to main content
OpenTrials
Completed

NCT Number: NCT00558571

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1245.4.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

BI 10773 low dose

Drug

placebo to BI 10773

Drug

BI 10773 medium dose

Drug

BI 10773 high dose

Drug

Primary outcomes

  1. Number of Subjects With Drug Related Adverse Events

    Time frame: from drug administration up to 6 weeks

    number of subjects with investigator-defined drug-related adverse events.

  2. Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG

    Time frame: 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 outcomes

  1. Cmax of Empagliflozin

    Time frame: 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).

  2. Tmax of Empagliflozin

    Time frame: 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.

  3. t1/2 of Empagliflozin

    Time frame: 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.

  4. AUC0-∞ of Empagliflozin

    Time frame: 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)

  5. CL/F of Empaglifozin

    Time frame: 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)

  6. fe0-24 of Empagliflozin

    Time frame: 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)

  7. LI (Linearity Index).

    Time frame: 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.

  8. Ae0-24 of Glucose

    Time frame: 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)

  9. Fasting Plasma Glucose (FPG)

    Time frame: in the morning of days -1 and 28

    fasting plasma glucose on day -1 (baseline) and change from baseline to day 28

  10. Mean Daily Glucose (MDG) Measured in Blood

    Time frame: 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.

  11. Insulin AUEC0-5

    Time frame: 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.

  12. Insulin Emax (Maximum Measured Effect)

    Time frame: 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

  13. Fasting Insulin

    Time frame: 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.

  14. Glucagon Emax (Maximum Measured Effect)

    Time frame: 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.

  15. Glucagon AUEC0-5

    Time frame: 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.

  16. Fructosamine

    Time frame: day -1 (baseline), 14 and 28

    change from baseline to days 14 and 18. Baseline is defined as day -1.

  17. HbA1c

    Time frame: in the morning of days -1 and 28

    change from baseline on day 28. Baseline is defined as day -1.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
First posted
Nov 15, 2007
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.