Type2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Adult, Developmental Phase II
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.
Interventions
DRUGDS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
DRUGSitagliptin
capsules
DRUGplacebo
matching DS-8500a tablets and sitagliptin capsules
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 No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in HbA1c | baseline (Day -1) to Week 12 | HbA1c = glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of subjects with HbA1c <7.0 | baseline (Day -1) to Week 12 | proportion of subjects who achieve HbA1c \<7.0 |
| change in plasma glucose | baseline (Day -1) to Week 4 | — |
| change in AUC derived from plasma glucose | baseline (Day -1) to Week 4 | change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax) |
| change in serum insulin | baseline (Day -1) to Week 4 | — |
| change in AUC 0-3h serum insulin | baseline (Day -1) to Week 4 | — |
| change in proinsulin | baseline (Day -1) to Week 4 | — |
| change in AUC 0-3h proinsulin | baseline (Day -1) to Week 4 | — |
| change in C-peptide | baseline (Day -1) to Week 4 | — |
| change in AUC 0-3h C-peptide | baseline (Day -1) to Week 4 | — |
| change in PYY | baseline (Day -1) to Week 4 | PYY = peptide YY |
| change in AUC 0-3h PYY | baseline (Day -1) to Week 4 | — |
| change in total GLP-1 | baseline (Day -1) to Week 4 | GLP-1 = Glucagon-Like Peptide-1 |
| change in total AUC 0-3h GLP-1 | baseline (Day -1) to Week 4 | — |
| change in HbA1c | baseline (Day -1) to Week 4 | — |
| change in active GLP-1 | baseline (Day -1) to Week 4 | — |
| change in AUC 0-3h active GLP-1 | baseline (Day -1) to Week 4 | — |
| change in total GIP | baseline (Day -1) to Week 4 | GIP = Gastric Inhibitory Polypeptide |
| change in AUC 0-3h total GIP | baseline (Day -1) to Week 4 | — |
| change in glucagon | baseline (Day -1) to Week 4 | — |
| change in AUC 0-3h glucagon | baseline (Day -1) to Week 4 | — |
| change in 1,5 AG | baseline (Day -1) to Week 4 | 1,5 AG = 1,5 anhydrogucitol |
| change in AUC 0-3h 1,5 AG | baseline (Day -1) to Week 4 | — |
| change in total cholesterol | baseline (Day -1) to Week 2 | — |
| change in HDL cholesterol | baseline (Day -1) to Week 2 | HDL = high density lipoprotein |
| change in LDL cholesterol | baseline (Day -1) to Week 2 | LDL = low density lipoprotein |
| change in triglyceride | baseline (Day -1) to Week 2 | — |
| change in AUC 0-3h total GLP-1 | baseline (Day -1) to Week 12 | — |
Countries
Japan
Outcome results
None listed