臨床研究等提出・公開システム

A phase 2, randomized, double-blind, placebo-controlled, add-on study of DS-8500a in Japanese patients with type 2 diabetes mellitus receiving sitagliptin

Daiichi Sankyo Co., Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

Randomized, double-blind, parallel-group study

2

Main Inclusion Criteria;
1) Japanese patients with type 2 diabetes mellitus
2) Patients aged >= 20 years
3) Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
4) Patients who have >= 7.0% and < 9.0% HbA1c

Main 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

Both

Type 2 Diabetes Mellitus

investigational material(s)
Generic name etc : DS-8500a
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : Oral

Change from baseline in 24hr-weighted mean glucose

- Change from baseline (Day -1) in fasting plasma glucose
- Change in plasma glucose, glycoalbumin, serum insulin, proinsulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon at each matched time point from baseline (Day -1)
- Change in pharmacodynamic parameters including plasma glucose, serum insulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon from baseline (Day -1) to Day 28
- Change from baseline (Day -1) in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride