A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- change in HbA1c
Study Overview
Brief Summary
The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.
Detailed Description
The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥ 20 years at the time of informed consent
- •Japanese patients with type 2 diabetes
- •Patients who have HbA1c ≥ 7.0% and < 10.0%
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
Arms & Interventions
DS-8500a 25 mg QD
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: DS-8500a (Drug)
DS-8500a 25 mg QD
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: placebo (Drug)
DS-8500a 50 mg QD
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: DS-8500a (Drug)
DS-8500a 50 mg QD
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: placebo (Drug)
DS-8500a 75 mg QD
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: DS-8500a (Drug)
DS-8500a 75 mg QD
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Intervention: placebo (Drug)
placebo
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
Intervention: placebo (Drug)
Sitagliptin
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
Intervention: Sitagliptin (Drug)
Sitagliptin
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
change in HbA1c
Time Frame: baseline (Day -1) to Week 12
HbA1c = glycated hemoglobin
Secondary Outcomes
- change in AUC 0-3h PYY(baseline (Day -1) to Week 12)
- change in total GLP-1(baseline (Day -1) to Week 12)
- change in AUC 0-3h total GLP-1(baseline (Day -1) to Week 12)
- change in active GLP-1(baseline (Day -1) to Week 12)
- change in AUC 0-3h active GLP-1(baseline (Day -1) to Week 12)
- change in C-peptide(baseline (Day -1) to Week 12)
- change in total cholesterol(baseline (Day -1) to Week 12)
- change in HDL cholesterol(baseline (Day -1) to Week 12)
- change in LDL cholesterol(baseline (Day -1) to Week 12)
- change in triglyceride(baseline (Day -1) to Week 12)
- change in total AUC 0-3h GLP-1(baseline (Day -1) to Week 4)
- change in plasma glucose(baseline (Day -1) to Week 12)
- change in AUC 0-3h serum insulin(baseline (Day -1) to Week 12)
- change in proinsulin(baseline (Day -1) to Week 12)
- change in HbA1c(baseline (Day -1) to Week 8)
- proportion of subjects with HbA1c <7.0(baseline (Day -1) to Week 12)
- change in AUC derived from plasma glucose(baseline (Day -1) to Week 12)
- change in serum insulin(baseline (Day -1) to Week 12)
- change in AUC 0-3h proinsulin(baseline (Day -1) to Week 12)
- change in AUC 0-3h C-peptide(baseline (Day -1) to Week 12)
- change in PYY(baseline (Day -1) to Week 12)
- change in total GIP(baseline (Day -1) to Week 12)
- change in AUC 0-3h total GIP(baseline (Day -1) to Week 12)
- change in glucagon(baseline (Day -1) to Week 12)
- change in AUC 0-3h glucagon(baseline (Day -1) to Week 12)
- change in 1,5 AG(baseline (Day -1) to Week 12)
- change in AUC 0-3h 1,5 AG(baseline (Day -1) to Week 12)