Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes
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.
Interventions
DRUGDSP-8658
Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
DRUGPlacebo
Placebo 2.5, 10, 20, 40 mg orally once daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Diabetic subjects * 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 Inclusion Criteria: Healthy subjects * 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.
Exclusion criteria
Diabetic subjects * Have a current or expected requirement for any antidiabetic or lipid-lowering drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments include physical examination, laboratory variables and ECG. | 20 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed