Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus
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.
Interventions
DRUG10mg DS-8500a tablet
DRUG75mg DS-8500a tablet
DRUGplacebo
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
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% if untreated with antidiabetic agent. * Patients who have HbA1c ≥ 6.5% and \< 9.5% if treated with antidiabetic agent.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in 24-hour weighted mean blood glucose | Day -1 (baseline) to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in blood fasting plasma glucose level | Day -1 (baseline) to Days 7, 14, 21, 28 | — |
| 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 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 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 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 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 glycoalbumin 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 |
| 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 |
| 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 |
| 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 |
Countries
Japan
Outcome results
None listed