An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Hakata-ku, Fukuoka, Japan, 812-0025
      • Souseikai Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (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 < 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS-8500a 75 mg once daily (QD); tablets, orally, once daily for up to 28 days	Drug: DS-8500a; tablets
Placebo Comparator: Placebo; tablets, orally, once daily for up to 28 days	Drug: placebo; tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-phase and Second-phase secretion Insulin	First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)	Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide	First-phase and Second-phase secretion (C-peptide)	Baseline to Day 28 (Period 1 and 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M value	M value：Mean of Glucose Infusion Rate from 90 to 120 min	Baseline to Day 28 (Period 1 and 2)
M/I value	M/I value：M value / steady-state Insulin	Baseline to Day 28 (Period 1 and 2)
Disposition Index	Disposition Index：Product of M value and First-phase secretion	Baseline to Day 28 (Period 1 and 2)
Number and severity of Adverse Events		Day 28 (Period 1 and 2)
plasma concentration of DS-8500a		Day 28 (Period 1 and 2)

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.
• Investigators: Principal Investigator: Hirotaka Watada, MD, PhD, Juntendo University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Adult; Type 2 Diabetes Mellitus; Developmental Phase II
• 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-J205

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