Type 2 Diabetes MellitusPhase 2NCT02222350
Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
A Phase 2 study testing 10mg DS-8500a tablet and 75mg DS-8500a tablet in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- 10mg DS-8500a tablet and 75mg DS-8500a tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Jan 2015
- 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 to 69 years
- 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 < 10.0% if untreated with antidiabetic agent.
- Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.
Who cannot join
- Patients aged ≥ 70 years at the time of informed consent
- Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
- Patients with fasting plasma glucose ≥ 240 mg/dL
Trial locations and contacts
1 site in 1 country.
Japan1 site
Heishinkai Medical Group Incorporated OCROM Clinic
Kasuga, Osaka, 565-0853
About this study
Official title: A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
Read the detailed description
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 10mg DS-8500a tablet, 75mg DS-8500a tablet, placebo
- Keywords
- type 2 diabetes mellitus
- 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.
10mg DS-8500a tabletDrug
75mg DS-8500a tabletDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a 10mg once daily | Experimental | 10mg DS-8500a tablet given orally once daily Receives: Drug: 10mg DS-8500a tablet |
| DS8500a 75 mg once daily | Experimental | 75mg DS-8500a tablet given orally once daily Receives: Drug: 75mg DS-8500a tablet |
| placebo to match DS-8500a tablet | Placebo comparator | placebo matching DS-8500a tablet 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 blood glucose
Measured: Day -1 (baseline) to Day 28
Secondary outcomes (12)
change in 24 hour weighted mean blood glucose
Measured: Day -1 (baseline) to Day 14
change in blood fasting plasma glucose level
Measured: Day -1 (baseline) to Days 7, 14, 21, 28
change in blood plasma glucose level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood insulin level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood C-peptide level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood active GLP-1 level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood PYY level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood HbA1c level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
change in blood glycoalbumin level
Change in the parameter at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
Number of subjects experiencing adverse events as a measure of safety
Number of subjects experiencing adverse events
Measured: Day -1 (baseline) to Day 28
pharmacokinetic profile of DS-8500a
Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2
Measured: Day -1 (baseline) to Day 28
change in postprandial plasma glucose level
Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1
Measured: Day -1 (baseline) to Days 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222350
- Sponsor's protocol ID
- DS8500-A-J201
- Status last verified
- Apr 2015
- First submitted
- 18 Aug 2014
- 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/
Publications
Inagaki N, Chou HS, Tsukiyama S, Washio T, Shiosakai K, Nakatsuka Y, Taguchi T. Glucose-lowering effects and safety of DS-8500a, a G protein-coupled receptor 119 agonist, in Japanese patients with type 2 diabetes: results of a randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study. BMJ Open Diabetes Res Care. 2017 Sep 29;5(1):e000424. doi: 10.1136/bmjdrc-2017-000424. eCollection 2017.
PubMed 29071087
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, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02222350
- Acronym / sponsor ID
- DS8500-A-J201
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Aug 2014 (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 this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
Detailed description
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
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 10mg once daily | Experimental | Drug: 10mg DS-8500a tablet10mg DS-8500a tablet given orally once daily |
| DS8500a 75 mg once daily | Experimental | Drug: 75mg DS-8500a tablet75mg DS-8500a tablet given orally once daily |
| placebo to match DS-8500a tablet | Placebo comparator | Drug: placeboplacebo matching DS-8500a tablet |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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% if untreated with antidiabetic agent.
- Patients who have HbA1c ≥ 6.5% and < 9.5% if treated with antidiabetic agent.
Key exclusion criteria (6 listed)
- Patients aged ≥ 70 years at the time of informed consent
- Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2
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 |
|---|---|---|
| 10mg DS-8500a tablet | Drug | DS-8500a 10mg once daily |
| 75mg DS-8500a tablet | Drug | DS8500a 75 mg once daily |
| placebo | Drug | placebo to match DS-8500a tablet |
Primary outcome
change in 24-hour weighted mean blood glucose
Time frame: Day -1 (baseline) to Day 28
12 secondary outcomes
change in 24 hour weighted mean blood glucose
Time frame: Day -1 (baseline) to Day 14
change in blood fasting plasma glucose level
Time frame: Day -1 (baseline) to Days 7, 14, 21, 28
change in blood plasma glucose level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood insulin level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood C-peptide level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood active GLP-1 level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood PYY level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood HbA1c level
Time frame: Day -1 (baseline) to Days 14 and 28
change in blood glycoalbumin level
Time frame: Day -1 (baseline) to Days 14 and 28
Number of subjects experiencing adverse events as a measure of safety
Time frame: Day -1 (baseline) to Day 28
pharmacokinetic profile of DS-8500a
Time frame: Day -1 (baseline) to Day 28
change in postprandial plasma glucose level
Time frame: Day -1 (baseline) to Days 14 and 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.
- Derived from this study: PubMed 29071087Inagaki N, Chou HS, Tsukiyama S, Washio T, Shiosakai K, Nakatsuka Y, Taguchi T. Glucose-lowering effects and safety of DS-8500a, a G protein-coupled receptor 119 agonist, in Japanese patients with type 2 diabetes: results of a randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study. BMJ Open Diabetes Res Care. 2017 Sep 29;5(1):e000424. doi: 10.1136/bmjdrc-2017-000424. eCollection 2017.
- 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/
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 10mg DS-8500a tablet and 75mg DS-8500a tablet 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 6 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 blood glucose (time frame: Day -1 (baseline) to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222350, which also lists 1 linked publication.
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.