Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus
NCT01316341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2014-06-17
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
Interventions
- DRUG
-
BI10773
patient to receive a tablet containing high dose BI10773 p.o. plus one placebo
- DRUG
-
patient to receive two placebos
- DRUG
-
patient to receive two placebos
- DRUG
-
patient to receive two placebos
- DRUG
-
BI10773
patient to receive a tablet containing low dose BI10773 p.o. plus one placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2012-01-31
Countries
- China
Study Locations
More Related Trials
-
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
NCT04018365 ·Status: UNKNOWN ·Phase: PHASE3
-
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
NCT01368081 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
NCT01874483 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
NCT01210001 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years
NCT04531462 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
NCT02211963 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes
NCT02212925 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS as Tablet in Patients With Type 2 Diabetes
NCT02183415 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes
NCT01282970 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects
NCT01248364 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
NCT02077452 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS in Patients With Type 2 Diabetes
NCT02183350 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults
NCT03766724 ·Status: COMPLETED ·Phase: PHASE1
-
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )
NCT04221152 ·Status: UNKNOWN ·Phase: PHASE3
-
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
NCT01952535 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin
NCT04431141 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
NCT01095653 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
NCT03199261 ·Status: COMPLETED ·Phase: PHASE1
-
BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
NCT02183324 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
NCT06988553 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Empagliflozin in GSD-Ib Patients
NCT05960617 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
NCT07018453 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
NCT00736879 ·Status: COMPLETED ·Phase: PHASE3
-
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
NCT01055652 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of TG103 in Subjects With Type 2 Diabetes
NCT04790006 ·Status: UNKNOWN ·Phase: PHASE1