An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

Official Title
-----------------
A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: DS-8500a
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 20 years at the time of informed consent Japanese patients with type 2 diabetes Patients who have HbA1c ≥ 7.0% and < 9.0% Exclusion Criteria: Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis Patients receiving or requiring treatment with insulin Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2 Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease Patients with fasting plasma glucose ≥ 240 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-8500a 75 mg once daily (QD)<br>tablets, orally, once daily for up to 28 days | Drug: DS-8500a<br>* tablets<br>|
| Placebo Comparator: Placebo<br>tablets, orally, once daily for up to 28 days | Drug: placebo<br>* tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-phase and Second-phase secretion Insulin | First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2) | Baseline to Day 28 (Period 1 and 2) | 
| First-phase and Second-phase secretion C-peptide | First-phase and Second-phase secretion (C-peptide) | Baseline to Day 28 (Period 1 and 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M value | M value：Mean of Glucose Infusion Rate from 90 to 120 min | Baseline to Day 28 (Period 1 and 2) | 
| M/I value | M/I value：M value / steady-state Insulin | Baseline to Day 28 (Period 1 and 2) | 
| Disposition Index | Disposition Index：Product of M value and First-phase secretion | Baseline to Day 28 (Period 1 and 2) | 
| Number and severity of Adverse Events |  | Day 28 (Period 1 and 2) | 
| plasma concentration of DS-8500a |  | Day 28 (Period 1 and 2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, Adult, Developmental Phase II