Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01316341

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31

Brief Summary

the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to Chinese female and male patients with type 2 diabetes will be investigated.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI10773 low dose Per Os(p.o.)

patient to receive a tablet containing low dose BI10773 Per Os(p.o.) plus one placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

patient to receive two placebos

BI10773

Intervention Type: DRUG

patient to receive a tablet containing low dose BI10773 p.o. plus one placebo

Placebo

patient to receive two placebos

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

patient to receive two placebos

BI10773 high dose Per Os(p.o.)

patient to receive a tablet containing high dose BI10773 Per Os(p.o.) plus one placebo

Group Type: EXPERIMENTAL

BI10773

Intervention Type: DRUG

patient to receive a tablet containing high dose BI10773 p.o. plus one placebo

Placebo

Intervention Type: DRUG

patient to receive two placebos

Interventions

BI10773

patient to receive a tablet containing high dose BI10773 p.o. plus one placebo

Intervention Type: DRUG

Placebo

patient to receive two placebos

Intervention Type: DRUG

Placebo

patient to receive two placebos

Intervention Type: DRUG

Placebo

patient to receive two placebos

Intervention Type: DRUG

BI10773

patient to receive a tablet containing low dose BI10773 p.o. plus one placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Chinese male and 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 thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization

2. Glycosylated haemoglobin A1(HbA1c)<=8.5% and >=7.0% at screening,age>=21 and age<=70 years (male and female patients),BMI>=19 and <=40 kg/m2

3. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Exclusion Criteria

1. Patient who did not discontinue the antidiabetic treatment with insulin or glitazones, DPP-IV at least before 12 weeks before randomization

2. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast at screening visit

3. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:

4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²) 6 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 7 Neurological disorders (such as epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG demonstration of a QTc interval >450 ms ) at screening visit

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1245.44.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Countries

China

References

Zhao X, Cui Y, Zhao S, Lang B, Broedl UC, Salsali A, Pinnetti S, Macha S. Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Single- and multiple-dose Once-daily Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, in Chinese Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Jul 1;37(7):1493-502. doi: 10.1016/j.clinthera.2015.05.001. Epub 2015 Jun 19.

Reference Type: DERIVED

PMID: 26101175 (View on PubMed)

Other Identifiers

1245.44

Identifier Type: -

Identifier Source: org_study_id