Type 2 Diabetes MellitusPhase 2NCT02685345
A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
A Phase 2 study testing DS-8500a 25 mg and DS-8500a 75 mg in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial 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. 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 25 mg and DS-8500a 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2016to Oct 2016
- Phase
- Phase 2
- 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
- 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%
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, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DS-8500a 25 mg, DS-8500a 75 mg, placebo
- Keywords
- Type 2 Diabetes Mellitus, sitagliptin, adult, Phase 2
- 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-8500a 25 mgDrug
DS-8500a 75 mgDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a 25 mg QD | Experimental | DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days Receives: Drug: DS-8500a 25 mg |
| DS-8500a 75 mg QD | Experimental | DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days Receives: Drug: DS-8500a 75 mg |
| placebo | Placebo comparator | placebo 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.
change in 24 hour weighted mean glucose
Measured: baseline (Day -1) to Day 28
Secondary outcomes (24)
change in fasting plasma glucose
Measured: baseline (Day -1) to Day 28
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
Measured: baseline (Day -1) and Day 28
change in glycoalbumin
Measured: baseline (Day -1) and Day 28
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
Measured: baseline (Day -1) and Day 28
change in proinsulin
Measured: baseline (Day -1) and Day 28
change in C-peptide
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Measured: baseline (Day -1) and Day 28
change in PYY (pancreatic peptide YY3-36)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Measured: baseline (Day -1) and Day 28
change in total GLP-1 (Glucagon-like peptide-1)
Measured: baseline (Day -1) and Day 28
change in active GLP-1 (Glucagon-like peptide-1)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Measured: baseline (Day -1) and Day 28
change in total GIP (Gastric inhibitory polypeptide)
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Measured: baseline (Day -1) and Day 28
change in total glucagon
Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast
Measured: baseline (Day -1) and Day 28
change in total total cholesterol
Measured: baseline (Day -1) to after dosing on Day 28
change in total HDL (high density lipoprotein) cholesterol
Measured: baseline (Day -1) to after dosing on Day 28
change in total LDL (low density lipoprotein) cholesterol
Measured: baseline (Day -1) to after dosing on Day 28
change in total triglyceride
Measured: baseline (Day -1) to after dosing on Day 28
number and severity of adverse events
Measured: baseline (Day -1) to after dosing on Day 28
change in derived plasma glucose AUC
change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived serum insulin AUC
change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived C-peptide AUC
change in pharmacodynamic parameters derived from C-peptide; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived PYY AUC
change in pharmacodynamic parameters derived from PYY; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived total GLP-1 AUC
change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived active GLP-1 AUC
change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived total GIP AUC
change in pharmacodynamic parameters derived from total GIP; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
change in derived glucagon AUC
change in pharmacodynamic parameters derived from glucagon; AUC0-4h
Measured: baseline (Day -1) to after dosing on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mediscience Planning, Inc.
- Responsible party
- Sponsor
- Investigators
- Yasuo Terauchi, MD, PhD, Principal investigator, Yokohama City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685345
- Sponsor's protocol ID
- DS8500-A-J204
- Status last verified
- Nov 2016
- First submitted
- 3 Feb 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, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin
- ClinicalTrials.gov ID
- NCT02685345
- Acronym / sponsor ID
- DS8500-A-J204
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, sitagliptin, adult, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mediscience Planning, Inc.
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DS-8500a 25 mg QD | Experimental | Drug: DS-8500a 25 mgDS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days |
| DS-8500a 75 mg QD | Experimental | Drug: DS-8500a 75 mgDS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days |
| placebo | Placebo comparator | Drug: placeboplacebo tablets, 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 (4 listed)
- 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%
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-8500a 25 mg | Drug | DS-8500a 25 mg QD |
| DS-8500a 75 mg | Drug | DS-8500a 75 mg QD |
| placebo | Drug | placebo |
Primary outcome
change in 24 hour weighted mean glucose
Time frame: baseline (Day -1) to Day 28
24 secondary outcomes
change in fasting plasma glucose
Time frame: baseline (Day -1) to Day 28
change in plasma glucose
Time frame: baseline (Day -1) and Day 28
change in glycoalbumin
Time frame: baseline (Day -1) and Day 28
change in serum insulin
Time frame: baseline (Day -1) and Day 28
change in proinsulin
Time frame: baseline (Day -1) and Day 28
change in C-peptide
Time frame: baseline (Day -1) and Day 28
change in PYY (pancreatic peptide YY3-36)
Time frame: baseline (Day -1) and Day 28
change in total GLP-1 (Glucagon-like peptide-1)
Time frame: baseline (Day -1) and Day 28
change in active GLP-1 (Glucagon-like peptide-1)
Time frame: baseline (Day -1) and Day 28
change in total GIP (Gastric inhibitory polypeptide)
Time frame: baseline (Day -1) and Day 28
change in total glucagon
Time frame: baseline (Day -1) and Day 28
change in total total cholesterol
Time frame: baseline (Day -1) to after dosing on Day 28
change in total HDL (high density lipoprotein) cholesterol
Time frame: baseline (Day -1) to after dosing on Day 28
change in total LDL (low density lipoprotein) cholesterol
Time frame: baseline (Day -1) to after dosing on Day 28
change in total triglyceride
Time frame: baseline (Day -1) to after dosing on Day 28
number and severity of adverse events
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived plasma glucose AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived serum insulin AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived C-peptide AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived PYY AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived total GLP-1 AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived active GLP-1 AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived total GIP AUC
Time frame: baseline (Day -1) to after dosing on Day 28
change in derived glucagon AUC
Time frame: baseline (Day -1) to after dosing on Day 28
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.
Yasuo Terauchi, MD, PhD principal investigator
Yokohama City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS-8500a 25 mg and DS-8500a 75 mg 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 4 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in 24 hour weighted mean glucose (time frame: baseline (Day -1) to Day 28). 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.