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

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ClinicalTrials.gov Identifier: NCT00558571
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: BI 10773 low dose Drug: placebo to BI 10773 Drug: BI 10773 medium dose Drug: BI 10773 high dose Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo to BI 10773
Experimental: BI 10773 low dose Drug: BI 10773 low dose
Experimental: BI 10773 medium dose Drug: BI 10773 medium dose
Experimental: BI 10773 high dose Drug: BI 10773 high dose


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 %
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558571


Locations
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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, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558571    
Other Study ID Numbers: 1245.4
EudraCT No 2007-002685-36
First Posted: November 15, 2007    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs