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

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
DS-8500a
Sitagliptin
placebo
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Adult, Developmental Phase II

Eligibility Criteria

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

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

Sites / Locations

  • Heishinkai Medical Group Incorporated OCROM Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

DS-8500a 25 mg QD

DS-8500a 50 mg QD

DS-8500a 75 mg QD

placebo

Sitagliptin

Arm Description

DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule

DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.

capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet

Outcomes

Primary Outcome Measures

change in HbA1c
HbA1c = glycated hemoglobin

Secondary Outcome Measures

change in HbA1c
change in HbA1c
proportion of subjects with HbA1c <7.0
proportion of subjects who achieve HbA1c <7.0
change in plasma glucose
change in plasma glucose
change in AUC derived from plasma glucose
change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)
change in AUC derived from plasma glucose
pharmacodynamics profile consists of AUC, Cmax, Tmax
change in serum insulin
change in AUC 0-3h serum insulin
change in serum insulin
change in AUC 0-3h serum insulin
change in proinsulin
change in AUC 0-3h proinsulin
change in proinsulin
change in AUC 0-3h proinsulin
change in C-peptide
change in AUC 0-3h C-peptide
change in C-peptide
change in AUC 0-3h C-peptide
change in PYY
PYY = peptide YY
change in AUC 0-3h PYY
change in PYY
change in AUC 0-3h PYY
change in total GLP-1
GLP-1 = Glucagon-Like Peptide-1
change in total AUC 0-3h GLP-1
change in total GLP-1
change in AUC 0-3h total GLP-1
change in active GLP-1
change in AUC 0-3h active GLP-1
change in active GLP-1
change in AUC 0-3h active GLP-1
change in total GIP
GIP = Gastric Inhibitory Polypeptide
change in AUC 0-3h total GIP
change in total GIP
change in AUC 0-3h total GIP
change in glucagon
change in AUC 0-3h glucagon
change in glucagon
change in AUC 0-3h glucagon
change in 1,5 AG
1,5 AG = 1,5 anhydrogucitol
change in AUC 0-3h 1,5 AG
change in 1,5 AG
change in AUC 0-3h 1,5 AG
change in total cholesterol
change in total cholesterol
change in total cholesterol
change in total cholesterol
change in HDL cholesterol
HDL = high density lipoprotein
change in HDL cholesterol
change in HDL cholesterol
change in HDL cholesterol
change in LDL cholesterol
LDL = low density lipoprotein
change in LDL cholesterol
change in LDL cholesterol
change in LDL cholesterol
change in triglyceride
change in triglyceride
change in triglyceride
change in triglyceride

Full Information

First Posted
December 9, 2015
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02628392
Brief Title
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
Official Title
A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Adult, Developmental Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DS-8500a 25 mg QD
Arm Type
Experimental
Arm Description
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
Arm Title
DS-8500a 50 mg QD
Arm Type
Experimental
Arm Description
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Arm Title
DS-8500a 75 mg QD
Arm Type
Experimental
Arm Description
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
Intervention Type
Drug
Intervention Name(s)
DS-8500a
Intervention Description
DS-8500a tablets 25mg, 50mg, 75mg
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching DS-8500a tablets and sitagliptin capsules
Primary Outcome Measure Information:
Title
change in HbA1c
Description
HbA1c = glycated hemoglobin
Time Frame
baseline (Day -1) to Week 12
Secondary Outcome Measure Information:
Title
change in HbA1c
Time Frame
baseline (Day -1) to Week 4
Title
change in HbA1c
Time Frame
baseline (Day -1) to Week 8
Title
proportion of subjects with HbA1c <7.0
Description
proportion of subjects who achieve HbA1c <7.0
Time Frame
baseline (Day -1) to Week 12
Title
change in plasma glucose
Time Frame
baseline (Day -1) to Week 4
Title
change in plasma glucose
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC derived from plasma glucose
Description
change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC derived from plasma glucose
Description
pharmacodynamics profile consists of AUC, Cmax, Tmax
Time Frame
baseline (Day -1) to Week 12
Title
change in serum insulin
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h serum insulin
Time Frame
baseline (Day -1) to Week 4
Title
change in serum insulin
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h serum insulin
Time Frame
baseline (Day -1) to Week 12
Title
change in proinsulin
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h proinsulin
Time Frame
baseline (Day -1) to Week 4
Title
change in proinsulin
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h proinsulin
Time Frame
baseline (Day -1) to Week 12
Title
change in C-peptide
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h C-peptide
Time Frame
baseline (Day -1) to Week 4
Title
change in C-peptide
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h C-peptide
Time Frame
baseline (Day -1) to Week 12
Title
change in PYY
Description
PYY = peptide YY
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h PYY
Time Frame
baseline (Day -1) to Week 4
Title
change in PYY
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h PYY
Time Frame
baseline (Day -1) to Week 12
Title
change in total GLP-1
Description
GLP-1 = Glucagon-Like Peptide-1
Time Frame
baseline (Day -1) to Week 4
Title
change in total AUC 0-3h GLP-1
Time Frame
baseline (Day -1) to Week 4
Title
change in total GLP-1
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h total GLP-1
Time Frame
baseline (Day -1) to Week 12
Title
change in active GLP-1
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h active GLP-1
Time Frame
baseline (Day -1) to Week 4
Title
change in active GLP-1
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h active GLP-1
Time Frame
baseline (Day -1) to Week 12
Title
change in total GIP
Description
GIP = Gastric Inhibitory Polypeptide
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h total GIP
Time Frame
baseline (Day -1) to Week 4
Title
change in total GIP
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h total GIP
Time Frame
baseline (Day -1) to Week 12
Title
change in glucagon
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h glucagon
Time Frame
baseline (Day -1) to Week 4
Title
change in glucagon
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h glucagon
Time Frame
baseline (Day -1) to Week 12
Title
change in 1,5 AG
Description
1,5 AG = 1,5 anhydrogucitol
Time Frame
baseline (Day -1) to Week 4
Title
change in AUC 0-3h 1,5 AG
Time Frame
baseline (Day -1) to Week 4
Title
change in 1,5 AG
Time Frame
baseline (Day -1) to Week 12
Title
change in AUC 0-3h 1,5 AG
Time Frame
baseline (Day -1) to Week 12
Title
change in total cholesterol
Time Frame
baseline (Day -1) to Week 2
Title
change in total cholesterol
Time Frame
baseline (Day -1) to Week 4
Title
change in total cholesterol
Time Frame
baseline (Day -1) to Week 8
Title
change in total cholesterol
Time Frame
baseline (Day -1) to Week 12
Title
change in HDL cholesterol
Description
HDL = high density lipoprotein
Time Frame
baseline (Day -1) to Week 2
Title
change in HDL cholesterol
Time Frame
baseline (Day -1) to Week 4
Title
change in HDL cholesterol
Time Frame
baseline (Day -1) to Week 8
Title
change in HDL cholesterol
Time Frame
baseline (Day -1) to Week 12
Title
change in LDL cholesterol
Description
LDL = low density lipoprotein
Time Frame
baseline (Day -1) to Week 2
Title
change in LDL cholesterol
Time Frame
baseline (Day -1) to Week 4
Title
change in LDL cholesterol
Time Frame
baseline (Day -1) to Week 8
Title
change in LDL cholesterol
Time Frame
baseline (Day -1) to Week 12
Title
change in triglyceride
Time Frame
baseline (Day -1) to Week 2
Title
change in triglyceride
Time Frame
baseline (Day -1) to Week 4
Title
change in triglyceride
Time Frame
baseline (Day -1) to Week 8
Title
change in triglyceride
Time Frame
baseline (Day -1) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Heishinkai Medical Group Incorporated OCROM Clinic
City
Suita-shi
State/Province
Osaka
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/

Learn more about this trial

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

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