A phase 2, randomized, double-blind, dose finding study of DS-8500a in Japanese patients with type 2 diabetes mellitus

Phase 2

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2080223014
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 335

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 < 10.0% 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified