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A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DS-8500a 25 mg
DS-8500a 75 mg
placebo
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, sitagliptin, adult, Phase 2

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Japanese patients with type 2 diabetes
  • Patients aged ≥ 20 years at the time of informed consent
  • Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DS-8500a 25 mg QD

DS-8500a 75 mg QD

placebo

Arm Description

DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days

DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days

placebo tablets, orally, once daily for up to 28 days

Outcomes

Primary Outcome Measures

change in 24 hour weighted mean glucose

Secondary Outcome Measures

change in fasting plasma glucose
change in plasma glucose
Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal
change in glycoalbumin
change in serum insulin
Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal
change in proinsulin
change in C-peptide
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
change in PYY (pancreatic peptide YY3-36)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
change in total GLP-1 (Glucagon-like peptide-1)
change in active GLP-1 (Glucagon-like peptide-1)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
change in total GIP (Gastric inhibitory polypeptide)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
change in total glucagon
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
change in total total cholesterol
change in total HDL (high density lipoprotein) cholesterol
change in total LDL (low density lipoprotein) cholesterol
change in total triglyceride
number and severity of adverse events
change in derived plasma glucose AUC
change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
change in derived serum insulin AUC
change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
change in derived C-peptide AUC
change in pharmacodynamic parameters derived from C-peptide; AUC0-4h
change in derived PYY AUC
change in pharmacodynamic parameters derived from PYY; AUC0-4h
change in derived total GLP-1 AUC
change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h
change in derived active GLP-1 AUC
change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h
change in derived total GIP AUC
change in pharmacodynamic parameters derived from total GIP; AUC0-4h
change in derived glucagon AUC
change in pharmacodynamic parameters derived from glucagon; AUC0-4h

Full Information

First Posted
February 3, 2016
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
Collaborators
Mediscience Planning, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02685345
Brief Title
A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
Collaborators
Mediscience Planning, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.
Detailed Description
In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, sitagliptin, adult, Phase 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DS-8500a 25 mg QD
Arm Type
Experimental
Arm Description
DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days
Arm Title
DS-8500a 75 mg QD
Arm Type
Experimental
Arm Description
DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablets, orally, once daily for up to 28 days
Intervention Type
Drug
Intervention Name(s)
DS-8500a 25 mg
Intervention Type
Drug
Intervention Name(s)
DS-8500a 75 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
change in 24 hour weighted mean glucose
Time Frame
baseline (Day -1) to Day 28
Secondary Outcome Measure Information:
Title
change in fasting plasma glucose
Time Frame
baseline (Day -1) to Day 28
Title
change in plasma glucose
Description
Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal
Time Frame
baseline (Day -1) and Day 28
Title
change in glycoalbumin
Time Frame
baseline (Day -1) and Day 28
Title
change in serum insulin
Description
Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal
Time Frame
baseline (Day -1) and Day 28
Title
change in proinsulin
Time Frame
baseline (Day -1) and Day 28
Title
change in C-peptide
Description
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Time Frame
baseline (Day -1) and Day 28
Title
change in PYY (pancreatic peptide YY3-36)
Description
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Time Frame
baseline (Day -1) and Day 28
Title
change in total GLP-1 (Glucagon-like peptide-1)
Time Frame
baseline (Day -1) and Day 28
Title
change in active GLP-1 (Glucagon-like peptide-1)
Description
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Time Frame
baseline (Day -1) and Day 28
Title
change in total GIP (Gastric inhibitory polypeptide)
Description
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Time Frame
baseline (Day -1) and Day 28
Title
change in total glucagon
Description
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Time Frame
baseline (Day -1) and Day 28
Title
change in total total cholesterol
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in total HDL (high density lipoprotein) cholesterol
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in total LDL (low density lipoprotein) cholesterol
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in total triglyceride
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
number and severity of adverse events
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived plasma glucose AUC
Description
change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived serum insulin AUC
Description
change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived C-peptide AUC
Description
change in pharmacodynamic parameters derived from C-peptide; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived PYY AUC
Description
change in pharmacodynamic parameters derived from PYY; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived total GLP-1 AUC
Description
change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived active GLP-1 AUC
Description
change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived total GIP AUC
Description
change in pharmacodynamic parameters derived from total GIP; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28
Title
change in derived glucagon AUC
Description
change in pharmacodynamic parameters derived from glucagon; AUC0-4h
Time Frame
baseline (Day -1) to after dosing on Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Japanese patients with type 2 diabetes Patients aged ≥ 20 years at the time of informed consent Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuo Terauchi, MD, PhD
Organizational Affiliation
Yokohama City University
Official's Role
Principal Investigator
Facility Information:
City
Yodogawaku
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/

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A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

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