Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

NCT01924767 | Completed Phase 1 Results

• 2 other identifiers: 1245.22007-000654-32
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests

  Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).

  day 1 to day 21

• Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results

  Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results

  day 1 to day 21

• Micturition Frequency

  Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.

  Baseline and Day 9

• Assessment of Tolerability by Investigator

  Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.

  day 21

Secondary Outcomes (17)

• Concentration of the Analyte in Plasma

  -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.

• Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)

  -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.

• Time to Maximum Concentration of the Analyte in Plasma

  -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.

• Terminal Rate Constant in Plasma

  -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.

• Half-life and Mean Residence Time of the Analyte in Plasma

  -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.

Study Arms (4)

BI 10773 (dose group 3)

EXPERIMENTAL

multiple doses as tablet

Drug: BI 10773 Placebo; Drug: BI 10773

BI 10773 (dose group 4)

EXPERIMENTAL

multiple doses as tablet

Drug: BI 10773; Drug: BI 10773 Placebo

BI 10773 (dose group 1)

EXPERIMENTAL

multiple doses as tablet

Drug: BI 10773 Placebo; Drug: BI 10773

BI 10773 (dose group 2)

EXPERIMENTAL

multiple doses as tablet

Drug: BI 10773 Placebo; Drug: BI 10773

Interventions

BI 10773 Placebo DRUG

po taken fasting with 240 mL water

BI 10773 (dose group 2)

BI 10773 DRUG

po taken fasting with 240 mL water

BI 10773 (dose group 4)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
• Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
• Age \>21 and Age \<70 years (male and hysterectomised female patients) Age \>60 and Age \<70 years (postmenopausal female patients)
• Body Mass Index (BMI) \>18.5 and \<40 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
• Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) on two consecutive days during washout.
• Glycosylated haemoglobin A1 (HbA1c) \>8.5% at screening
• Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
• Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
• Renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²)
• Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
• Neurological disorders (such as epilepsy) or psychiatric disorders
• Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
• Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
• A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1245.2.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: July 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-07

Locations

DE (1)