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
- Not Applicable
- Intervention
- placebo
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- First-phase and Second-phase secretion Insulin
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.
Investigators
Eligibility Criteria
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 \< 9.0%
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
Placebo
tablets, orally, once daily for up to 28 days
Intervention: placebo
DS-8500a 75 mg once daily (QD)
tablets, orally, once daily for up to 28 days
Intervention: DS-8500a
Outcomes
Primary Outcomes
First-phase and Second-phase secretion Insulin
Time Frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
Time Frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion (C-peptide)
Secondary Outcomes
- M/I value(Baseline to Day 28 (Period 1 and 2))
- Number and severity of Adverse Events(Day 28 (Period 1 and 2))
- plasma concentration of DS-8500a(Day 28 (Period 1 and 2))
- M value(Baseline to Day 28 (Period 1 and 2))
- Disposition Index(Baseline to Day 28 (Period 1 and 2))