A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
61
1 country
1
Brief Summary
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Oct 2008
Shorter than P25 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2008
CompletedFirst Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2009
CompletedNovember 14, 2024
November 1, 2024
4 months
November 11, 2008
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of safety through clinical safety labs and adverse events
6 Weeks
Secondary Outcomes (1)
Evaluation of routine PK and PD parameters
6 Weeks
Study Arms (5)
ASP1941 Lowest Dose
EXPERIMENTALOral
ASP1941 Low Dose
EXPERIMENTALOral
ASP1941 Medium Dose
EXPERIMENTALOral
ASP1941 High Dose
EXPERIMENTALOral
Placebo
PLACEBO COMPARATOROral
Interventions
Eligibility Criteria
You may qualify if:
- Established diagnosis of type 2 diabetes mellitus
- HbA1c value between 7.0 and 10.0%
- Body mass index between 20 and 45 kg/m2
You may not qualify if:
- Established diagnosis of type 1 diabetes mellitus
- Serum creatinine \> upper limit of normal range
- Proteinuria (microalbumin/creatinine ratio \> 300 mg/g)
- Urinary tract infection
- Severe uncontrolled Hypertension
- Significant renal, hepatic or cardiovascular disease
- HIV Positive
- History of drug or alcohol abuse/dependency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
use Central Contact
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2008
First Posted
November 13, 2008
Study Start
October 23, 2008
Primary Completion
March 6, 2009
Study Completion
March 6, 2009
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.