| Trial ID: | L4407 |
| Source ID: | NCT02529449
|
| Associated Drug: |
Placebo
|
| Title: |
Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Placebo|DRUG: ASP1941
|
| Outcome Measures: |
Primary: Daily profile of plasma glucose levels, up to Day 14|Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels, at Day -1, Day 1 and Day 14|AUC0-3h of plasma glucose levels, at Day -1, Day 1 and Day 14|AUC0-4h of plasma glucose levels, up to Day 14|AUC0-10h of plasma glucose levels, up to Day 14|Fasting plasma glucose levels, up to Day 21|Glycoalbumin, up to Day 21|Urinary glucose excretion, up to Day 14|Urinary glucose excretion rate, up to Day 14|Urine volume, up to Day 14|Urinary glucose concentration, up to Day 15|Body weight, up to Day 21|Renal glucose clearance, up to Day 14|Plasma concentration of unchanged ASP1941, up to Day 14|Urinary concentration of unchanged ASP1941, up to Day 14|Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf), at Day 1|PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast), at Day 1 and Day 14|PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h), at Day 1 and Day 14|PK parameter of ASP1941 in plasma: Oral Clearance (CL/F), at Day 1 and Day 14|PK parameter of ASP1941 in plasma: Maximum concentration (Cmax), at Day 1 and Day 14|PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2), at Day 1 and Day 14|PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax), at Day 1 and Day 14|PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae), at Day 1 and Day 14|PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%), at Day 1 and Day 14|PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr), at Day 1 and Day 14|Safety assessed by vital signs, Supine blood pressure and supine pulse rate, up to Day 21|Safety assessed by 12-lead electrocardiogram, up to Day 21|Safety assessed by laboratory tests, Hematology, biochemistry and urinalysis, up to Day 21|Safety assessed by self-monitored blood glucose levels, up to Day 21|Safety assessed by Adverse events, up to Day 21 |
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
43
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09-01
|
| Completion Date: |
2016-03-19
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Site JP00006, Aichi, Japan|Site JP00002, Fukuoka, Japan|Site JP00009, Gunma, Japan|Site JP00001, Ibaraki, Japan|Site JP00005, Kanagawa, Japan|Site JP00008, Kanagawa, Japan|Site JP00003, Okayama, Japan|Site JP00004, Osaka, Japan|Site JP00010, Osaka, Japan|Site JP00011, Osaka, Japan|Site JP00007, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02529449
|
