JPRN-jRCT2080223072
Unknown
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- DAIICHI SANKYO CO., LTD.
- Enrollment
- 20
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Main Inclusion Criteria;
- •1\)Patients aged \>\= 20 years
- •2\)Japanese patients with type 2 diabetes mellitus
- •3\)Patients who have \>\= 7\.0% and \< 9\.0% HbA1c
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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