Clinical trial NCT02222350: Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
Official title: A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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% 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

Primary outcomes:
measure: change in 24-hour weighted mean blood glucose
timeFrame: Day -1 (baseline) to Day 28
Secondary outcomes:
measure: change in 24 hour weighted mean blood glucose
timeFrame: Day -1 (baseline) to Day 14
measure: change in blood fasting plasma glucose level
timeFrame: Day -1 (baseline) to Days 7, 14, 21, 28
measure: change in blood plasma glucose level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood insulin level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood C-peptide level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood active GLP-1 level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood PYY level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood HbA1c level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: change in blood glycoalbumin level
timeFrame: Day -1 (baseline) to Days 14 and 28
measure: Number of subjects experiencing adverse events as a measure of safety
timeFrame: Day -1 (baseline) to Day 28
measure: pharmacokinetic profile of DS-8500a
timeFrame: Day -1 (baseline) to Day 28
measure: change in postprandial plasma glucose level
timeFrame: Day -1 (baseline) to Days 14 and 28
Other outcomes:
Locations:
city: Kasuga
country: Japan
facility: Heishinkai Medical Group Incorporated OCROM Clinic
state: Osaka
Study officials:
References:
citation: Inagaki N, Chou HS, Tsukiyama S, Washio T, Shiosakai K, Nakatsuka Y, Taguchi T. Glucose-lowering effects and safety of DS-8500a, a G protein-coupled receptor 119 agonist, in Japanese patients with type 2 diabetes: results of a randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study. BMJ Open Diabetes Res Care. 2017 Sep 29;5(1):e000424. doi: 10.1136/bmjdrc-2017-000424. eCollection 2017.