NCT02669732

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 12, 2019

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

January 27, 2016

Last Update Submit

February 8, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusAdultDevelopmental Phase II

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • M value

    Baseline to Day 28 (Period 1 and 2)

  • M/I value

    Baseline to Day 28 (Period 1 and 2)

  • Disposition Index

    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)

Study Arms (2)

DS-8500a 75 mg once daily (QD)

EXPERIMENTAL

tablets, orally, once daily for up to 28 days

Drug: DS-8500a

Placebo

PLACEBO COMPARATOR

tablets, orally, once daily for up to 28 days

Drug: placebo

Interventions

DS-8500aDRUG

tablets

DS-8500a 75 mg once daily (QD)
placeboDRUG

tablets

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOUSEIKAI Hakata Clinic

Hakata-ku, Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

firuglipel

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hirotaka Watada, MD, PhD

    Juntendo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 1, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

February 12, 2019

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
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.
More information

Locations

JP(1)