A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

February 8, 2019 updated by: Daiichi Sankyo Co., Ltd.

A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita-shi, Osaka, Japan
        • Heishinkai Medical Group Incorporated OCROM Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 < 10.0%

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DS-8500a 25 mg QD
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
Drug: DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
Drug: placebo
matching DS-8500a tablets and sitagliptin capsules
Experimental: DS-8500a 50 mg QD
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Drug: DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
Drug: placebo
matching DS-8500a tablets and sitagliptin capsules
Experimental: DS-8500a 75 mg QD
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Drug: DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
Drug: placebo
matching DS-8500a tablets and sitagliptin capsules
Placebo Comparator: placebo
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
Drug: placebo
matching DS-8500a tablets and sitagliptin capsules
Active Comparator: Sitagliptin
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
Drug: placebo
matching DS-8500a tablets and sitagliptin capsules
Drug: Sitagliptin
capsules
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in HbA1c
Time Frame: baseline (Day -1) to Week 12
HbA1c = glycated hemoglobin
baseline (Day -1) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in HbA1c
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in HbA1c
Time Frame: baseline (Day -1) to Week 8
baseline (Day -1) to Week 8
proportion of subjects with HbA1c <7.0
Time Frame: baseline (Day -1) to Week 12
proportion of subjects who achieve HbA1c <7.0
baseline (Day -1) to Week 12
change in plasma glucose
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in plasma glucose
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC derived from plasma glucose
Time Frame: baseline (Day -1) to Week 4
change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)
baseline (Day -1) to Week 4
change in AUC derived from plasma glucose
Time Frame: baseline (Day -1) to Week 12
pharmacodynamics profile consists of AUC, Cmax, Tmax
baseline (Day -1) to Week 12
change in serum insulin
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in AUC 0-3h serum insulin
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in serum insulin
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h serum insulin
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in proinsulin
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in AUC 0-3h proinsulin
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in proinsulin
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h proinsulin
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in C-peptide
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in AUC 0-3h C-peptide
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in C-peptide
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h C-peptide
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in PYY
Time Frame: baseline (Day -1) to Week 4
PYY = peptide YY
baseline (Day -1) to Week 4
change in AUC 0-3h PYY
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in PYY
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h PYY
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in total GLP-1
Time Frame: baseline (Day -1) to Week 4
GLP-1 = Glucagon-Like Peptide-1
baseline (Day -1) to Week 4
change in total AUC 0-3h GLP-1
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in total GLP-1
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h total GLP-1
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in active GLP-1
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in AUC 0-3h active GLP-1
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in active GLP-1
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h active GLP-1
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in total GIP
Time Frame: baseline (Day -1) to Week 4
GIP = Gastric Inhibitory Polypeptide
baseline (Day -1) to Week 4
change in AUC 0-3h total GIP
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in total GIP
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h total GIP
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in glucagon
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in AUC 0-3h glucagon
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in glucagon
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h glucagon
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in 1,5 AG
Time Frame: baseline (Day -1) to Week 4
1,5 AG = 1,5 anhydrogucitol
baseline (Day -1) to Week 4
change in AUC 0-3h 1,5 AG
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in 1,5 AG
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in AUC 0-3h 1,5 AG
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in total cholesterol
Time Frame: baseline (Day -1) to Week 2
baseline (Day -1) to Week 2
change in total cholesterol
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in total cholesterol
Time Frame: baseline (Day -1) to Week 8
baseline (Day -1) to Week 8
change in total cholesterol
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in HDL cholesterol
Time Frame: baseline (Day -1) to Week 2
HDL = high density lipoprotein
baseline (Day -1) to Week 2
change in HDL cholesterol
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in HDL cholesterol
Time Frame: baseline (Day -1) to Week 8
baseline (Day -1) to Week 8
change in HDL cholesterol
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in LDL cholesterol
Time Frame: baseline (Day -1) to Week 2
LDL = low density lipoprotein
baseline (Day -1) to Week 2
change in LDL cholesterol
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in LDL cholesterol
Time Frame: baseline (Day -1) to Week 8
baseline (Day -1) to Week 8
change in LDL cholesterol
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12
change in triglyceride
Time Frame: baseline (Day -1) to Week 2
baseline (Day -1) to Week 2
change in triglyceride
Time Frame: baseline (Day -1) to Week 4
baseline (Day -1) to Week 4
change in triglyceride
Time Frame: baseline (Day -1) to Week 8
baseline (Day -1) to Week 8
change in triglyceride
Time Frame: baseline (Day -1) to Week 12
baseline (Day -1) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS8500-A-J203

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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