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

Sumitomo Pharma America, Inc.1 site in 1 country40 target enrollmentNovember 2009

ConditionsType 2 Diabetes Mellitus

InterventionsDSP-8658 Placebo

DrugsDSP-8658 Placebo

Overview

Phase: Phase 1
Intervention: DSP-8658
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Safety assessments include physical examination, laboratory variables and ECG.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

July 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•Exclusion Criteria: Healthy subjects
•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

Arms & Interventions

DSP-8658

DSP-8658 2.5, 10, 20, 40 mg once daily

Intervention: DSP-8658

Placebo

Placebo 2.5, 10, 20, and 40 mg doses once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Safety assessments include physical examination, laboratory variables and ECG.

Time Frame: 20 days

Secondary Outcomes

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)