A phase 2, randomized, double-blind, placebo-controlled, add-on study of DS-8500a in Japanese patients with type 2 diabetes mellitus receiving sitaglipti
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080223082
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 90
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/d
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in 24hr-weighted mean glucose
- Secondary Outcome Measures
Name Time Method -Change from baseline (Day -1) in fasting plasma glucose<br>-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) <br>-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<br>-Change from baseline (Day -1) in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride