Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Nov 2009
Typical duration for phase_1 type-2-diabetes-mellitus
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedSeptember 16, 2013
September 1, 2013
8 months
December 21, 2009
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessments include physical examination, laboratory variables and ECG.
20 days
Secondary Outcomes (2)
Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study.
20 days
Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study.
18 days
Study Arms (2)
DSP-8658
EXPERIMENTALDSP-8658 2.5, 10, 20, 40 mg once daily
Placebo
PLACEBO COMPARATORPlacebo 2.5, 10, 20, and 40 mg doses once daily
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≤45
- Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≥ 18 and ≤ 29
- Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.
You may not qualify if:
- Have a current or expected requirement for any antidiabetic or lipid-lowering drug
- Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cetero Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2009
First Posted
January 5, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 16, 2013
Record last verified: 2013-09