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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558571
First received: November 14, 2007
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Subjects With Drug Related Adverse Events [ Time Frame: from drug administration up to 6 weeks ] [ Designated as safety issue: No ]
    number of subjects with investigator-defined drug-related adverse events.

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG [ Time Frame: from drug administration up to 6 weeks ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)

  • 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 ] [ Designated as safety issue: No ]
    Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)

  • 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 ] [ Designated as safety issue: No ]
    The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.

  • 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 ] [ Designated as safety issue: No ]
    Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)

  • Fasting Plasma Glucose (FPG) [ Time Frame: in the morning of days -1 and 28 ] [ Designated as safety issue: No ]
    fasting plasma glucose on day -1 (baseline) and change from baseline to day 28

  • 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 ] [ Designated as safety issue: No ]
    change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.

  • 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. ] [ Designated as safety issue: No ]
    change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.

  • 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. ] [ Designated as safety issue: No ]
    change in Emax from baseline on day 28. Baseline is defined as day -1

  • Fasting Insulin [ Time Frame: in the morning of days -1( baseline), 1, 7, 14, 21 and 28 ] [ Designated as safety issue: No ]
    Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.

  • 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. ] [ Designated as safety issue: No ]
    Change from baseline (day -1) in Emax on day 28.

  • 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. ] [ Designated as safety issue: No ]
    Change from baseline (day -1) in AUEC0-5 on day 28.

  • Fructosamine [ Time Frame: day -1 (baseline), 14 and 28 ] [ Designated as safety issue: No ]
    change from baseline to days 14 and 18. Baseline is defined as day -1.

  • HbA1c [ Time Frame: in the morning of days -1 and 28 ] [ Designated as safety issue: No ]
    change from baseline on day 28. Baseline is defined as day -1.


Enrollment: 78
Study Start Date: January 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558571

Locations
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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558571     History of Changes
Other Study ID Numbers: 1245.4, EudraCT No 2007-002685-36
Study First Received: November 14, 2007
Results First Received: May 16, 2014
Last Updated: July 16, 2014
Health Authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014