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:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558571
First received: November 14, 2007
Last updated: October 31, 2013
Last verified: October 2013
  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
Drug: placebo to BI 10773
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
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:
  • Increase in urine volume (micturition diary) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with abnormalities in physical examination [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with changes in vital signs (blood pressure (BP), pulse rate (PR)) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with abnormalities in 12-lead ECG (electrocardiogram) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with abnormalities in clinical laboratory tests (haematology, clinical chemistry, urinalysis, counter-regulatory hormones and free fatty acids) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum concentration) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • C24,1 (concentration of analyte in plasma at 24 hours post-drug administration after administration of the first dose) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Aet1-t2 (amount of analyte that is eliminated in urine over the time interval t1 to t2 h) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • fe t1-t2 (fraction of analyte excreted unchanged in urine from time points t1 to t2 h) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 24 h data) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • MRTpo (mean residence time of the analyte in the body after first dose) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • C24,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N) [ Time Frame: 5 min before administration of dose N ] [ Designated as safety issue: No ]
  • C24,ss (concentration of analyte in plasma at 24 h post-drug administration at steady state) [ Time Frame: 5 min before last dose ] [ Designated as safety issue: No ]
  • tmax,ss (time from dosing to maximum concentration at steady state) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • AUCτ,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady-state) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • MRTpo,ss (mean residence time of the analyte in the body at steady state) [ Time Frame: up to 96 hours after last dose ] [ Designated as safety issue: No ]
  • CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state). [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • Ae t1-t2,ss (amount of analyte that is eliminated in urine at steady state over the time interval t1 to t2 h) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • fe t1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval t1 to t2 h) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • CLR,ss (renal clearance of the analyte at steady state) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • Cavg (average concentration) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • PTF (peak trough fluctuation) [ Time Frame: up to 24 hours after last dose ] [ Designated as safety issue: No ]
  • LI (linearity index). [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Urinary glucose Excretion [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • 8 point weighted mean daily glucose (MDG) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Oral glucose tolerance tests [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Efficacy biomarker HbA1c, fructosamine and 1,5 anhydroglucitol In the morning [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and 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
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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, 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
Last Updated: October 31, 2013
Health Authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)

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

ClinicalTrials.gov processed this record on April 22, 2014