Type 2 Diabetes MellitusNCT02669732
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
A study testing DS-8500a in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DS-8500a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DS-8500a, placebo
- Keywords
- Type 2 Diabetes Mellitus, Adult, Developmental Phase II
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-8500aDrug
tablets
placeboDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a 75 mg once daily (QD) | Experimental | tablets, orally, once daily for up to 28 days Receives: Drug: DS-8500a |
| Placebo | Placebo comparator | tablets, orally, once daily for up to 28 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-phase and Second-phase secretion Insulin
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
Measured: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
First-phase and Second-phase secretion (C-peptide)
Measured: Baseline to Day 28 (Period 1 and 2)
Secondary outcomes (5)
M value
M value：Mean of Glucose Infusion Rate from 90 to 120 min
Measured: Baseline to Day 28 (Period 1 and 2)
M/I value
M/I value：M value / steady-state Insulin
Measured: Baseline to Day 28 (Period 1 and 2)
Disposition Index
Disposition Index：Product of M value and First-phase secretion
Measured: Baseline to Day 28 (Period 1 and 2)
Number and severity of Adverse Events
Measured: Day 28 (Period 1 and 2)
plasma concentration of DS-8500a
Measured: Day 28 (Period 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hirotaka Watada, MD, PhD, Principal investigator, Juntendo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669732
- Sponsor's protocol ID
- DS8500-A-J205
- Status last verified
- Dec 2016
- First submitted
- 27 Jan 2016
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02669732
- Acronym / sponsor ID
- DS8500-A-J205
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Adult, Developmental Phase II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS-8500a 75 mg once daily (QD) | Experimental | Drug: DS-8500atablets, orally, once daily for up to 28 days |
| Placebo | Placebo comparator | Drug: placebotablets, orally, once daily for up to 28 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-8500atablets | Drug | DS-8500a 75 mg once daily (QD) |
| placebotablets | Drug | Placebo |
Primary outcome
First-phase and Second-phase secretion Insulin
Time frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
Time frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion (C-peptide)
5 secondary outcomes
M value
Time frame: Baseline to Day 28 (Period 1 and 2)
M/I value
Time frame: Baseline to Day 28 (Period 1 and 2)
Disposition Index
Time frame: Baseline to Day 28 (Period 1 and 2)
Number and severity of Adverse Events
Time frame: Day 28 (Period 1 and 2)
plasma concentration of DS-8500a
Time frame: Day 28 (Period 1 and 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirotaka Watada, MD, PhD principal investigator
Juntendo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DS-8500a in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-phase and Second-phase secretion Insulin (time frame: Baseline to Day 28 (Period 1 and 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.