Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.

Detailed Description
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The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.

Official Title
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A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: 10mg DS-8500a tablet
* Drug: 75mg DS-8500a tablet
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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 < 10.0% if untreated with antidiabetic agent. Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent. Exclusion Criteria: Patients aged ≥ 70 years at the time of informed consent Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2 Patients with fasting plasma glucose ≥ 240 mg/dL

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: DS-8500a 10mg once daily<br>10mg DS-8500a tablet given orally once daily | Drug: 10mg DS-8500a tablet<br> <br> |
| Experimental: DS8500a 75 mg once daily<br>75mg DS-8500a tablet given orally once daily | Drug: 75mg DS-8500a tablet<br> <br> |
| Placebo Comparator: placebo to match DS-8500a tablet<br>placebo matching DS-8500a tablet | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 24-hour weighted mean blood glucose |  | Day -1 (baseline) to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 24 hour weighted mean blood glucose |  | Day -1 (baseline) to Day 14 | 
| change in blood fasting plasma glucose level |  | Day -1 (baseline) to Days 7, 14, 21, 28 | 
| change in blood plasma glucose level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood insulin level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood C-peptide level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood active GLP-1 level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood PYY level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood HbA1c level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| change in blood glycoalbumin level | Change in the parameter at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 
| Number of subjects experiencing adverse events as a measure of safety | Number of subjects experiencing adverse events | Day -1 (baseline) to Day 28 | 
| pharmacokinetic profile of DS-8500a | Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2 | Day -1 (baseline) to Day 28 | 
| change in postprandial plasma glucose level | Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1 | Day -1 (baseline) to Days 14 and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus