| Trial ID: | L7224 |
| Source ID: | NCT00707954
|
| Associated Drug: |
Ta-7284
|
| Title: |
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00707954/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: TA-7284|DRUG: Placebo of TA-7284
|
| Outcome Measures: |
Primary: Safety: Adverse Events, Adverse Drug Reactions, In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose., 19 days | Secondary: Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr, 19 days|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin, 18 days
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
61
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2009-02
|
| Results First Posted: |
2014-04-28
|
| Last Update Posted: |
2014-04-28
|
| Locations: |
P-One Clinic, Hachioji-city, Tokyo-to, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00707954
|
