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Completed

NCT Number: NCT00885118

4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1245.15.003 Boehringer Ingelheim Investigational Site, Hachioji, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
  • Hemoglobin A1c (HbA1c) at screening (Visit 1)
  • For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
  • For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
  • Age between 20 and 70 years
  • Body mass index (BMI) between18.0 and 40.0 kg/m2
  • Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria

  • Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
  • Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
  • Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
  • Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as
  • Renal insufficiency (calculated estimated glomerular filtration rate <60)
  • Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of >160/95 mmHg,
  • Neurological disorders (such as epilepsy) or psychiatric disorders
  • Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
  • Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
  • Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
  • Statins.
  • Antihypertensives (diuretics not allowed)
  • alpha-Blockers for benign prostate hypertrophy
  • Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
  • Additional inclusion/exclusion criteria apply

Treatment and study plan

Placebo (middle dose)

Drug

Placebo tablets once a day

Placebo

Drug

Placebo tablets once a day

BI 10773

Drug

BI 10773 middle dose tablets once a day

Placebo (high dose)

Drug

Placebo tablets once a day

Placebo (low dose)

Drug

Placebo tablets once a day

Primary outcomes

  1. Change From Baseline in Urine Glucose Excretion

    Time frame: baseline and 28 days

    Change from baseline in Urine glucose excretion to 28 days

  2. Change From Baseline in Fasting Plasma Glucose

    Time frame: baseline and 28 days

    Change from baseline in Fasting plasma glucose to 28 days

  3. Change From Baseline in 8-point Glucose

    Time frame: baseline and 27 days

    Change from baseline in 8-point glucose to 27 days

Secondary outcomes

  1. Change From Baseline in HbA1c

    Time frame: baseline and 28 days

    Change from baseline in HbA1c to 28 days

  2. Change From Baseline in Fructosamine

    Time frame: baseline and 28 days

    Change from baseline in Fructosamine to 28 days

  3. Change From Baseline in 1,5-anhydroglucitol

    Time frame: baseline and 28 days

    Change from baseline in 1,5-anhydroglucitol to 28 days

  4. Change From Baseline in Fasting Insulin

    Time frame: baseline and 28 days

    Change from baseline in Fasting insulin to 28 days

  5. Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

    Time frame: baseline and 28 days

    Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

  6. Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

    Time frame: baseline and 28 days

    Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

  7. Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

    Time frame: baseline and 28 days

    Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

  8. AUCτ,1

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ

  9. AUC0-tz

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration

  10. AUC0-∞

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

  11. Cmax

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    maximum measured concentration of the analyte in plasma

  12. t1/2

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    terminal half-life of the analyte in plasma

  13. CL/F

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    apparent clearance of the analyte in plasma after extravascular administration

  14. Vz/F

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

    apparent volume of distribution during the terminal phase λz following an extravascular dose

  15. Ae0-24

    Time frame: 0-5, 5-12, 12-24 hour after first drug administration

    amount of the analyte that is eliminated in urine over the time interval 0 to 24

  16. fe0-24

    Time frame: 0-5, 5-12, 12-24 hour after first drug administration

    fraction of the analyte excreted unchanged in urine from time interval 0 to 24

  17. CLR,0-24

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration

    renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data

  18. AUCτ,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

    area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state

  19. Cmax,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

    maximum measured concentration of the analyte in plasma at steady state

  20. t1/2,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

    terminal half-life of the analyte in plasma at steady state

  21. CL/F,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

    apparent clearance of the analyte in plasma after extravascular administration at steady state

  22. Vz/F,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

    apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state

  23. RA,Cmax

    Time frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

    accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax

  24. RA,AUC

    Time frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

    accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ

  25. Ae0-24,ss

    Time frame: 0-5, 5-12, 12-24 hour after last drug administration

    amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24

  26. fe0-24,ss

    Time frame: 0-5, 5-12, 12-24 hour after last drug administration

    fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24

  27. CLR,ss

    Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration

    renal clearance of the analyte at steady state determined over the dosing interval τ

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2009
First posted
Apr 21, 2009
Registry last updated
Nov 25, 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.

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