Type2 Diabetes MellitusNCT02628392
A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
A study testing DS-8500a and Sitagliptin in people with Type2 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, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- DS-8500a and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2015to Sep 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 < 10.0%
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, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- DS-8500a, Sitagliptin, 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
DS-8500a tablets 25mg, 50mg, 75mg
SitagliptinDrug
Also called Januvia
capsules
placeboDrug
matching DS-8500a tablets and sitagliptin capsules
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a 25 mg QD | Experimental | DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule Receives: Drug: DS-8500a; Drug: placebo |
| DS-8500a 50 mg QD | Experimental | DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule Receives: Drug: DS-8500a; Drug: placebo |
| DS-8500a 75 mg QD | Experimental | DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule Receives: Drug: DS-8500a; Drug: placebo |
| placebo | Placebo comparator | placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively. Receives: Drug: placebo |
| Sitagliptin | Active comparator | capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet Receives: Drug: Sitagliptin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c
HbA1c = glycated hemoglobin
Measured: baseline (Day -1) to Week 12
Secondary outcomes (59)
change in HbA1c
Measured: baseline (Day -1) to Week 4
change in HbA1c
Measured: baseline (Day -1) to Week 8
proportion of subjects with HbA1c <7.0
proportion of subjects who achieve HbA1c <7.0
Measured: baseline (Day -1) to Week 12
change in plasma glucose
Measured: baseline (Day -1) to Week 4
change in plasma glucose
Measured: baseline (Day -1) to Week 12
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)
Measured: baseline (Day -1) to Week 4
change in AUC derived from plasma glucose
pharmacodynamics profile consists of AUC, Cmax, Tmax
Measured: baseline (Day -1) to Week 12
change in serum insulin
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h serum insulin
Measured: baseline (Day -1) to Week 4
change in serum insulin
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h serum insulin
Measured: baseline (Day -1) to Week 12
change in proinsulin
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h proinsulin
Measured: baseline (Day -1) to Week 4
change in proinsulin
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h proinsulin
Measured: baseline (Day -1) to Week 12
change in C-peptide
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h C-peptide
Measured: baseline (Day -1) to Week 4
change in C-peptide
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h C-peptide
Measured: baseline (Day -1) to Week 12
change in PYY
PYY = peptide YY
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h PYY
Measured: baseline (Day -1) to Week 4
change in PYY
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h PYY
Measured: baseline (Day -1) to Week 12
change in total GLP-1
GLP-1 = Glucagon-Like Peptide-1
Measured: baseline (Day -1) to Week 4
change in total AUC 0-3h GLP-1
Measured: baseline (Day -1) to Week 4
change in total GLP-1
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h total GLP-1
Measured: baseline (Day -1) to Week 12
change in active GLP-1
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h active GLP-1
Measured: baseline (Day -1) to Week 4
change in active GLP-1
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h active GLP-1
Measured: baseline (Day -1) to Week 12
change in total GIP
GIP = Gastric Inhibitory Polypeptide
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h total GIP
Measured: baseline (Day -1) to Week 4
change in total GIP
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h total GIP
Measured: baseline (Day -1) to Week 12
change in glucagon
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h glucagon
Measured: baseline (Day -1) to Week 4
change in glucagon
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h glucagon
Measured: baseline (Day -1) to Week 12
change in 1,5 AG
1,5 AG = 1,5 anhydrogucitol
Measured: baseline (Day -1) to Week 4
change in AUC 0-3h 1,5 AG
Measured: baseline (Day -1) to Week 4
change in 1,5 AG
Measured: baseline (Day -1) to Week 12
change in AUC 0-3h 1,5 AG
Measured: baseline (Day -1) to Week 12
change in total cholesterol
Measured: baseline (Day -1) to Week 2
change in total cholesterol
Measured: baseline (Day -1) to Week 4
change in total cholesterol
Measured: baseline (Day -1) to Week 8
change in total cholesterol
Measured: baseline (Day -1) to Week 12
change in HDL cholesterol
HDL = high density lipoprotein
Measured: baseline (Day -1) to Week 2
change in HDL cholesterol
Measured: baseline (Day -1) to Week 4
change in HDL cholesterol
Measured: baseline (Day -1) to Week 8
change in HDL cholesterol
Measured: baseline (Day -1) to Week 12
change in LDL cholesterol
LDL = low density lipoprotein
Measured: baseline (Day -1) to Week 2
change in LDL cholesterol
Measured: baseline (Day -1) to Week 4
change in LDL cholesterol
Measured: baseline (Day -1) to Week 8
change in LDL cholesterol
Measured: baseline (Day -1) to Week 12
change in triglyceride
Measured: baseline (Day -1) to Week 2
change in triglyceride
Measured: baseline (Day -1) to Week 4
change in triglyceride
Measured: baseline (Day -1) to Week 8
change in triglyceride
Measured: baseline (Day -1) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 368 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
- NCT02628392
- Sponsor's protocol ID
- DS8500-A-J203
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2015
- 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, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02628392
- Acronym / sponsor ID
- DS8500-A-J203
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Adult, Developmental Phase II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Dec 2015 (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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DS-8500a 25 mg QD | Experimental | Drug: DS-8500a, Drug: placeboDS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule |
| DS-8500a 50 mg QD | Experimental | Drug: DS-8500a, Drug: placeboDS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule |
| DS-8500a 75 mg QD | Experimental | Drug: DS-8500a, Drug: placeboDS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule |
| placebo | Placebo comparator | Drug: placeboplacebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively. |
| Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: placebocapsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet |
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 < 10.0%
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-8500aDS-8500a tablets 25mg, 50mg, 75mg | Drug | DS-8500a 25 mg QD, DS-8500a 50 mg QD, DS-8500a 75 mg QD |
| SitagliptinAlso: Januviacapsules | Drug | Sitagliptin |
| placebomatching DS-8500a tablets and sitagliptin capsules | Drug | DS-8500a 25 mg QD, DS-8500a 50 mg QD, DS-8500a 75 mg QD, Sitagliptin, placebo |
Primary outcome
change in HbA1c
Time frame: baseline (Day -1) to Week 12
HbA1c = glycated hemoglobin
59 secondary outcomes
change in HbA1c
Time frame: baseline (Day -1) to Week 4
change in HbA1c
Time frame: baseline (Day -1) to Week 8
proportion of subjects with HbA1c <7.0
Time frame: baseline (Day -1) to Week 12
change in plasma glucose
Time frame: baseline (Day -1) to Week 4
change in plasma glucose
Time frame: baseline (Day -1) to Week 12
change in AUC derived from plasma glucose
Time frame: baseline (Day -1) to Week 4
change in AUC derived from plasma glucose
Time frame: baseline (Day -1) to Week 12
change in serum insulin
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h serum insulin
Time frame: baseline (Day -1) to Week 4
change in serum insulin
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h serum insulin
Time frame: baseline (Day -1) to Week 12
change in proinsulin
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h proinsulin
Time frame: baseline (Day -1) to Week 4
change in proinsulin
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h proinsulin
Time frame: baseline (Day -1) to Week 12
change in C-peptide
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h C-peptide
Time frame: baseline (Day -1) to Week 4
change in C-peptide
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h C-peptide
Time frame: baseline (Day -1) to Week 12
change in PYY
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h PYY
Time frame: baseline (Day -1) to Week 4
change in PYY
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h PYY
Time frame: baseline (Day -1) to Week 12
change in total GLP-1
Time frame: baseline (Day -1) to Week 4
change in total AUC 0-3h GLP-1
Time frame: baseline (Day -1) to Week 4
change in total GLP-1
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GLP-1
Time frame: baseline (Day -1) to Week 12
change in active GLP-1
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h active GLP-1
Time frame: baseline (Day -1) to Week 4
change in active GLP-1
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h active GLP-1
Time frame: baseline (Day -1) to Week 12
change in total GIP
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h total GIP
Time frame: baseline (Day -1) to Week 4
change in total GIP
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GIP
Time frame: baseline (Day -1) to Week 12
change in glucagon
Time frame: baseline (Day -1) to Week 4
change in AUC 0-3h glucagon
Time frame: baseline (Day -1) to Week 4
change in glucagon
Time frame: baseline (Day -1) to Week 12
change in AUC 0-3h glucagon
Time frame: baseline (Day -1) to Week 12
change in 1,5 AG
Time frame: baseline (Day -1) to Week 4
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.
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 study testing DS-8500a and Sitagliptin in people with Type2 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?
change in HbA1c (time frame: baseline (Day -1) to Week 12). 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.