search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
DS-8500a
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, 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 < 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

  • SOUSEIKAI Hakata Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DS-8500a 75 mg once daily (QD)

Placebo

Arm Description

tablets, orally, once daily for up to 28 days

tablets, orally, once daily for up to 28 days

Outcomes

Primary Outcome Measures

First-phase and Second-phase secretion Insulin
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
First-phase and Second-phase secretion (C-peptide)

Secondary Outcome Measures

M value
M value：Mean of Glucose Infusion Rate from 90 to 120 min
M/I value
M/I value：M value / steady-state Insulin
Disposition Index
Disposition Index：Product of M value and First-phase secretion
Number and severity of Adverse Events
plasma concentration of DS-8500a

Full Information

First Posted
January 27, 2016
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02669732
Brief Title
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 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.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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, Adult, Developmental Phase II

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DS-8500a 75 mg once daily (QD)
Arm Type
Experimental
Arm Description
tablets, orally, once daily for up to 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
tablets, orally, once daily for up to 28 days
Intervention Type
Drug
Intervention Name(s)
DS-8500a
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablets
Primary Outcome Measure Information:
Title
First-phase and Second-phase secretion Insulin
Description
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
Time Frame
Baseline to Day 28 (Period 1 and 2)
Title
First-phase and Second-phase secretion C-peptide
Description
First-phase and Second-phase secretion (C-peptide)
Time Frame
Baseline to Day 28 (Period 1 and 2)
Secondary Outcome Measure Information:
Title
M value
Description
M value：Mean of Glucose Infusion Rate from 90 to 120 min
Time Frame
Baseline to Day 28 (Period 1 and 2)
Title
M/I value
Description
M/I value：M value / steady-state Insulin
Time Frame
Baseline to Day 28 (Period 1 and 2)
Title
Disposition Index
Description
Disposition Index：Product of M value and First-phase secretion
Time Frame
Baseline to Day 28 (Period 1 and 2)
Title
Number and severity of Adverse Events
Time Frame
Day 28 (Period 1 and 2)
Title
plasma concentration of DS-8500a
Time Frame
Day 28 (Period 1 and 2)

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 < 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
Hirotaka Watada, MD, PhD
Organizational Affiliation
Juntendo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SOUSEIKAI Hakata Clinic
City
Hakata-ku
State/Province
Fukuoka
ZIP/Postal Code
812-0025
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

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

We'll reach out to this number within 24 hrs