Clinical trial NCT02685345: A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
sitagliptin
adult
Phase 2
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Mediscience Planning, Inc.
First posted: 2016-02-18
Enrollment: 85
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 and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

Detailed description: In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Eligibility criteria: Inclusion Criteria:

* Japanese patients with type 2 diabetes
* Patients aged ≥ 20 years at the time of informed consent
* Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
* 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

Primary outcomes:
measure: change in 24 hour weighted mean glucose
timeFrame: baseline (Day -1) to Day 28
Secondary outcomes:
measure: change in fasting plasma glucose
timeFrame: baseline (Day -1) to Day 28
measure: change in plasma glucose
timeFrame: baseline (Day -1) and Day 28
measure: change in glycoalbumin
timeFrame: baseline (Day -1) and Day 28
measure: change in serum insulin
timeFrame: baseline (Day -1) and Day 28
measure: change in proinsulin
timeFrame: baseline (Day -1) and Day 28
measure: change in C-peptide
timeFrame: baseline (Day -1) and Day 28
measure: change in PYY (pancreatic peptide YY3-36)
timeFrame: baseline (Day -1) and Day 28
measure: change in total GLP-1 (Glucagon-like peptide-1)
timeFrame: baseline (Day -1) and Day 28
measure: change in active GLP-1 (Glucagon-like peptide-1)
timeFrame: baseline (Day -1) and Day 28
measure: change in total GIP (Gastric inhibitory polypeptide)
timeFrame: baseline (Day -1) and Day 28
measure: change in total glucagon
timeFrame: baseline (Day -1) and Day 28
measure: change in total total cholesterol
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in total HDL (high density lipoprotein) cholesterol
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in total LDL (low density lipoprotein) cholesterol
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in total triglyceride
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: number and severity of adverse events
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived plasma glucose AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived serum insulin AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived C-peptide AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived PYY AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived total GLP-1 AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived active GLP-1 AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived total GIP AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
measure: change in derived glucagon AUC
timeFrame: baseline (Day -1) to after dosing on Day 28
Other outcomes:
Locations:
city: Yodogawaku
country: Japan
state: Osaka
Study officials:
affiliation: Yokohama City University
name: Yasuo Terauchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: