A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

Daiichi Sankyo Co., Ltd.85 enrolled

Overview

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

DS-8500a 25 mgDRUG

DS-8500a 75 mgDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese patients with type 2 diabetes * Patients aged ≥ 20 years at the time of informed consent * Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus * 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

Locations (1)

Unnamed facility

Yodogawaku, Osaka, Japan

Outcomes

Primary Outcomes

change in 24 hour weighted mean glucose

Time frame: baseline (Day -1) to Day 28

Secondary Outcomes

change in fasting plasma glucose

Time frame: baseline (Day -1) to Day 28

change in plasma glucose

Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal

Time frame: baseline (Day -1) and Day 28

change in glycoalbumin

Time frame: baseline (Day -1) and Day 28

change in serum insulin

Time frame: baseline (Day -1) and Day 28

change in proinsulin

Time frame: baseline (Day -1) and Day 28

change in C-peptide

Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

Time frame: baseline (Day -1) and Day 28

change in PYY (pancreatic peptide YY3-36)

Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

Time frame: baseline (Day -1) and Day 28

change in total GLP-1 (Glucagon-like peptide-1)

Data from ClinicalTrials.gov

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Time frame: baseline (Day -1) and Day 28

change in active GLP-1 (Glucagon-like peptide-1)

Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

Time frame: baseline (Day -1) and Day 28

change in total GIP (Gastric inhibitory polypeptide)

Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

Time frame: baseline (Day -1) and Day 28

change in total glucagon

Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast

Time frame: baseline (Day -1) and Day 28

change in total total cholesterol