Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: placebo; Drug: 10mg DS-8500a tablet; Drug: 75mg DS-8500a tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Kasuga, Osaka, Japan, 565-0853
      • Heishinkai Medical Group Incorporated OCROM Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS-8500a 10mg once daily; 10mg DS-8500a tablet given orally once daily	Drug: 10mg DS-8500a tablet
Experimental: DS8500a 75 mg once daily; 75mg DS-8500a tablet given orally once daily	Drug: 75mg DS-8500a tablet
Placebo Comparator: placebo to match DS-8500a tablet; placebo matching DS-8500a tablet	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in 24-hour weighted mean blood glucose	Day -1 (baseline) to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 24 hour weighted mean blood glucose		Day -1 (baseline) to Day 14
change in blood fasting plasma glucose level		Day -1 (baseline) to Days 7, 14, 21, 28
change in blood plasma glucose level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood insulin level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood C-peptide level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood active GLP-1 level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood PYY level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood HbA1c level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
change in blood glycoalbumin level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Number of subjects experiencing adverse events as a measure of safety	Number of subjects experiencing adverse events	Day -1 (baseline) to Day 28
pharmacokinetic profile of DS-8500a	Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2	Day -1 (baseline) to Day 28
change in postprandial plasma glucose level	Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Firuglipel
• Other Study ID Numbers: DS8500-A-J201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR