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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: DSP-8658
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSP-8658<br>DSP-8658 2.5, 10, 20, 40 mg once daily | Drug: DSP-8658<br>* Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily<br>|
| Placebo Comparator: Placebo<br>Placebo 2.5, 10, 20, and 40 mg doses once daily | Drug: Placebo<br>* Placebo 2.5, 10, 20, 40 mg orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments include physical examination, laboratory variables and ECG. |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes