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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00885118
First received: April 20, 2009
Last updated: May 16, 2014
Last verified: May 2014

April 20, 2009
May 16, 2014
April 2009
October 2009   (final data collection date for primary outcome measure)
  • Change From Baseline in Urine Glucose Excretion [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in Urine glucose excretion to 28 days
  • Change From Baseline in Fasting Plasma Glucose [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in Fasting plasma glucose to 28 days
  • Change From Baseline in 8-point Glucose [ Time Frame: baseline and 27 days ] [ Designated as safety issue: No ]
    Change from baseline in 8-point glucose to 27 days
Urine glucose excretion Plasma glucose [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00885118 on ClinicalTrials.gov Archive Site
  • Change From Baseline in HbA1c [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c to 28 days
  • Change From Baseline in Fructosamine [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in Fructosamine to 28 days
  • Change From Baseline in 1,5-anhydroglucitol [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in 1,5-anhydroglucitol to 28 days
  • Change From Baseline in Fasting Insulin [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change from baseline in Fasting insulin to 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) [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ
  • 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 ] [ Designated as safety issue: No ]
    area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration
  • 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 ] [ 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
  • 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 ] [ Designated as safety issue: No ]
    maximum measured concentration of the analyte in plasma
  • 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 ] [ Designated as safety issue: No ]
    terminal half-life of the analyte in plasma
  • 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 ] [ Designated as safety issue: No ]
    apparent clearance of the analyte in plasma after extravascular administration
  • 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 ] [ Designated as safety issue: No ]
    apparent volume of distribution during the terminal phase λz following an extravascular dose
  • Ae0-24 [ Time Frame: 0-5, 5-12, 12-24 hour after first drug administration ] [ Designated as safety issue: No ]
    amount of the analyte that is eliminated in urine over the time interval 0 to 24
  • fe0-24 [ Time Frame: 0-5, 5-12, 12-24 hour after first drug administration ] [ Designated as safety issue: No ]
    fraction of the analyte excreted unchanged in urine from time interval 0 to 24
  • 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 ] [ Designated as safety issue: No ]
    renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data
  • 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 ] [ Designated as safety issue: No ]
    area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state
  • 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 ] [ Designated as safety issue: No ]
    maximum measured concentration of the analyte in plasma at steady state
  • 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 ] [ Designated as safety issue: No ]
    terminal half-life of the analyte in plasma at steady state
  • 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 ] [ Designated as safety issue: No ]
    apparent clearance of the analyte in plasma after extravascular administration at steady state
  • 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 ] [ Designated as safety issue: No ]
    apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state
  • 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 ] [ Designated as safety issue: No ]
    accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax
  • 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 ] [ Designated as safety issue: No ]
    accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ
  • Ae0-24,ss [ Time Frame: 0-5, 5-12, 12-24 hour after last drug administration ] [ Designated as safety issue: No ]
    amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24
  • fe0-24,ss [ Time Frame: 0-5, 5-12, 12-24 hour after last drug administration ] [ Designated as safety issue: No ]
    fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24
  • 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 ] [ Designated as safety issue: No ]
    renal clearance of the analyte at steady state determined over the dosing interval τ
HbA1c Fructosamine 1.5 anhydroglucitol [ Time Frame: 28 days ]
Not Provided
Not Provided
 
4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo (middle dose)
    Placebo tablets once a day
  • Drug: Placebo
    Placebo tablets once a day
  • Drug: BI 10773
    BI 10773 middle dose tablets once a day
  • Drug: BI 10773
    BI 10773 high dose tablets once a day
  • Drug: Placebo (high dose)
    Placebo tablets once a day
  • Drug: BI 10773
    BI 10773 low dose tablets once a day
  • Drug: Placebo (low dose)
    Placebo tablets once a day
  • Experimental: BI 10773 low dose quaque die (QD)
    patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo (low dose)
  • Experimental: BI 10773 mid-low dose QD
    patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
    Interventions:
    • Drug: Placebo (middle dose)
    • Drug: BI 10773
  • Experimental: BI 10773 mid-high dose QD
    patient to receive two tablets of BI 10773 middle dose once daily
    Intervention: Drug: BI 10773
  • Experimental: BI 10773 high dose QD
    patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo (high dose)
  • Placebo Comparator: Placebo
    patient to receive two tablets of placebo once daily
    Intervention: Drug: Placebo
Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
October 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
  2. 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%.
  3. Age between 20 and 70 years
  4. Body mass index (BMI) between18.0 and 40.0 kg/m2
  5. 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:

  1. 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
  2. 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.
  3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
  4. 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
  5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

    • Statins.
    • Antihypertensives (diuretics not allowed)
    • Beta-Blockers for benign prostate hypertrophy
    • Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00885118
1245.15
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP