Clinical trial NCT02628392: A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Official title: A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Adult
Developmental Phase II
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 368
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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

Primary outcomes:
measure: change in HbA1c
timeFrame: baseline (Day -1) to Week 12
Secondary outcomes:
measure: change in HbA1c
timeFrame: baseline (Day -1) to Week 4
measure: change in HbA1c
timeFrame: baseline (Day -1) to Week 8
measure: proportion of subjects with HbA1c <7.0
timeFrame: baseline (Day -1) to Week 12
measure: change in plasma glucose
timeFrame: baseline (Day -1) to Week 4
measure: change in plasma glucose
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC derived from plasma glucose
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC derived from plasma glucose
timeFrame: baseline (Day -1) to Week 12
measure: change in serum insulin
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h serum insulin
timeFrame: baseline (Day -1) to Week 4
measure: change in serum insulin
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h serum insulin
timeFrame: baseline (Day -1) to Week 12
measure: change in proinsulin
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h proinsulin
timeFrame: baseline (Day -1) to Week 4
measure: change in proinsulin
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h proinsulin
timeFrame: baseline (Day -1) to Week 12
measure: change in C-peptide
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h C-peptide
timeFrame: baseline (Day -1) to Week 4
measure: change in C-peptide
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h C-peptide
timeFrame: baseline (Day -1) to Week 12
measure: change in PYY
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h PYY
timeFrame: baseline (Day -1) to Week 4
measure: change in PYY
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h PYY
timeFrame: baseline (Day -1) to Week 12
measure: change in total GLP-1
timeFrame: baseline (Day -1) to Week 4
measure: change in total AUC 0-3h GLP-1
timeFrame: baseline (Day -1) to Week 4
measure: change in total GLP-1
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h total GLP-1
timeFrame: baseline (Day -1) to Week 12
measure: change in active GLP-1
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h active GLP-1
timeFrame: baseline (Day -1) to Week 4
measure: change in active GLP-1
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h active GLP-1
timeFrame: baseline (Day -1) to Week 12
measure: change in total GIP
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h total GIP
timeFrame: baseline (Day -1) to Week 4
measure: change in total GIP
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h total GIP
timeFrame: baseline (Day -1) to Week 12
measure: change in glucagon
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h glucagon
timeFrame: baseline (Day -1) to Week 4
measure: change in glucagon
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h glucagon
timeFrame: baseline (Day -1) to Week 12
measure: change in 1,5 AG
timeFrame: baseline (Day -1) to Week 4
measure: change in AUC 0-3h 1,5 AG
timeFrame: baseline (Day -1) to Week 4
measure: change in 1,5 AG
timeFrame: baseline (Day -1) to Week 12
measure: change in AUC 0-3h 1,5 AG
timeFrame: baseline (Day -1) to Week 12
measure: change in total cholesterol
timeFrame: baseline (Day -1) to Week 2
measure: change in total cholesterol
timeFrame: baseline (Day -1) to Week 4
measure: change in total cholesterol
timeFrame: baseline (Day -1) to Week 8
measure: change in total cholesterol
timeFrame: baseline (Day -1) to Week 12
measure: change in HDL cholesterol
timeFrame: baseline (Day -1) to Week 2
measure: change in HDL cholesterol
timeFrame: baseline (Day -1) to Week 4
measure: change in HDL cholesterol
timeFrame: baseline (Day -1) to Week 8
measure: change in HDL cholesterol
timeFrame: baseline (Day -1) to Week 12
measure: change in LDL cholesterol
timeFrame: baseline (Day -1) to Week 2
measure: change in LDL cholesterol
timeFrame: baseline (Day -1) to Week 4
measure: change in LDL cholesterol
timeFrame: baseline (Day -1) to Week 8
measure: change in LDL cholesterol
timeFrame: baseline (Day -1) to Week 12
measure: change in triglyceride
timeFrame: baseline (Day -1) to Week 2
measure: change in triglyceride
timeFrame: baseline (Day -1) to Week 4
measure: change in triglyceride
timeFrame: baseline (Day -1) to Week 8
measure: change in triglyceride
timeFrame: baseline (Day -1) to Week 12
Other outcomes:
Locations:
city: Suita-shi
country: Japan
facility: Heishinkai Medical Group Incorporated OCROM Clinic
state: Osaka
Study officials:
References: