Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: DSP-8658; Drug: Placebo

• Registration Number: NCT01042106
• Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2010-01-03
• Study First Posted: 2010-01-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSP-8658	DSP-8658	DSP-8658 2.5, 10, 20, 40 mg once daily
Placebo	Placebo	Placebo 2.5, 10, 20, and 40 mg doses once daily

Primary Outcome Measures

Name	Time	Method
Safety assessments include physical examination, laboratory variables and ECG.	20 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cetero Research; 🇺🇸 San Antonio, Texas, United States