Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: 10mg DS-8500a tabletDrug: 75mg DS-8500a tabletDrug: placebo
- Registration Number
- NCT02222350
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
- Detailed Description
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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% if untreated with antidiabetic agent.
- Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.
- Patients aged ≥ 70 years at the time of informed consent
- Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
- Patients with fasting plasma glucose ≥ 240 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DS-8500a 10mg once daily 10mg DS-8500a tablet 10mg DS-8500a tablet given orally once daily DS8500a 75 mg once daily 75mg DS-8500a tablet 75mg DS-8500a tablet given orally once daily placebo to match DS-8500a tablet placebo placebo matching DS-8500a tablet
- Primary Outcome Measures
Name Time Method change in 24-hour weighted mean blood glucose Day -1 (baseline) to Day 28
- Secondary Outcome Measures
Name Time Method change in blood HbA1c level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in blood fasting plasma glucose level Day -1 (baseline) to Days 7, 14, 21, 28 change in blood insulin level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in blood active GLP-1 level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in 24 hour weighted mean blood glucose Day -1 (baseline) to Day 14 change in blood plasma glucose level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in blood C-peptide level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in blood glycoalbumin level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
change in blood PYY level Day -1 (baseline) to Days 14 and 28 Change in the parameter at Day 14 or 28 from Day -1
Number of subjects experiencing adverse events as a measure of safety Day -1 (baseline) to Day 28 Number of subjects experiencing adverse events
change in postprandial plasma glucose level Day -1 (baseline) to Days 14 and 28 Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1
pharmacokinetic profile of DS-8500a Day -1 (baseline) to Day 28 Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2
Trial Locations
- Locations (1)
Heishinkai Medical Group Incorporated OCROM Clinic
🇯🇵Kasuga, Osaka, Japan
Heishinkai Medical Group Incorporated OCROM Clinic🇯🇵Kasuga, Osaka, Japan