Type 2 Diabetes MellitusPhase 1NCT02004678
Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
A Phase 1 study testing DS-1150b in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 1 site in United States.
Trial summary
DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus. This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single center study to assess the safety… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DS-1150b
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2013
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All Subjects:
- All women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. Women must be of non-childbearing potential, either:
- Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dose administration).
- <60 years of age and naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dose administration, with a follicle stimulating hormone (FSH) level at screening of
- ≥40 mIU/mL.
- >60 years of age and naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dose administration.
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- Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral until 12 weeks following the last dose administration. In addition, the male subjects must not donate sperm after the study for a period of 12 weeks.
- Subjects must give written informed consent to participate in the study prior to screening.
- Subjects must be in good health as determined by screening medical history, physical examination findings, vital signs measurement, ECGs, serum chemistry, hematology, virology (ie, HIV, HBV, and HCV at screening only), and urinalysis performed at screening and on Day -1.
- Subjects must agree to abstain from grapefruit/grapefruit juice and Seville oranges from 10 days before the first dose and throughout the study.
- All subjects must have a negative fecal occult blood test.
- Part B (Type 2 Diabetes Mellitus):
- Men and women who are not of childbearing potential, 18 years to 60 years of age, inclusive.
- A BMI of 25 kg/m2 to 38 kg/m2, inclusive.
- Diagnosis of Type 2 DM for a minimum of 3 months prior to first dose.
- Subjects should be either:
- On metformin alone with a hemoglobin A1c (HBA1c) value between 7% to 9.5%, inclusive.
- Treatment naïve or treatment free from any antidiabetic treatment for at least 3 months prior to screening with a HBA1c value between 7% to 10%, inclusive.
- Subjects with fasting plasma glucose ≥100 mg/dL and ≤250 mg/dL, for screening and on Day -1.
Who cannot join
- All Subjects:
- History of gastrointestinal ulcer or erosion, or rhabdomyolysis within 6 months of dose administration.
- Subjects with laboratory results outside the normal range, if considered clinically significant by the Investigator.
- Subjects with serum K above the ULN of the clinical laboratory's reference range at screening and on Day -1.
- Subjects with CPK above the ULN at screening and on Day -1.
- Subjects with lactate above the ULN at screening and on Day -1.
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- Subjects with QTcF interval duration >450 msec, obtained as an average from the 3 ECG recorder's measurements on the triplicate screening ECGs (3 ECGs in close succession at least 1 min apart) taken after at least 10 minutes of quiet rest in supine position.
- Subjects with abnormal waveform morphology on any of the ECGs at the screening and on Day -1 that would preclude accurate measurement of the QT interval duration.
- History of any serious disorder, including cardiovascular, hematologic, pulmonary, hepatic, renal, gastrointestinal, skeletal, connective tissue disease, uncontrolled endocrine/metabolic other than subjects with Type 2 DM in Part B, oncologic (within the last 5 years), neurologic, and psychiatric diseases, or any disorder that may prevent the successful completion of the study.
- Subjects who have had physical trauma, surgery or a significant illness within 4 weeks prior to the first dose.
- Donated or lost >500 mL of blood or plasma within 3 months prior to the first dose on Day 1.
- Participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marked drug within the 30 days prior to administration of the first dose.
- Part B (Type 2 Diabetes Mellitus)
- History of Type 1 diabetes and/or history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- History of severe microvascular or macrovascular complications of Type 2 DM, including proliferative retinopathy, macroalbuminuria, peripheral neuropathy, ischemic heart disease, stroke, and peripheral vascular disease.
- History of diabetic neuropathy.
- Need for any concomitant medication that is moderate or strong CYP inhibitors including CYP3A4, CYP2D6, CYP2C9, and CYP2C19, or P-gp inhibitor. Need for other antidiabetic drugs except for metformin. Other common concomitant medications in diabetic patients may be allowed (eg, aspirin and thyroid hormones) upon agreement between the Sponsor and the PI.
- Subjects with liver function of ALT and AST above 1.25 × ULN, or total bilirubin above ULN at screening and on Day -1.
- Moderate or severe renal dysfunction, defined as eGFR (using MDRD equation) <60 mL/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Single-Blind, Placebo-Controlled, Randomized, Two-Part, Sequential, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus. This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of DS-1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DS-1150b, Placebo
- 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-1150bDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, 7.5 mg DS-1150b | Other | Dosing will occur over two periods. Subjects will receive either
* a dose of placebo in Period 1 followed by a single dose of 7.5 mg DS-1150b in Period 2; or
* a single dose of 7.5 mg DS-1150b in Period 1 followed by a dose of placebo in Period 2. Receives: Drug: DS-1150b; Other: Placebo |
| Cohort 2, 15 mg DS-1150b | Other | Dosing will occur over two periods. Subjects will receive either
* a dose of placebo in Period 1 followed by a single dose of 15 mg DS-1150b in Period 2; or
* a single dose of 15 mg DS-1150b in Period 1 followed by a dose of placebo in Period 2. Receives: Drug: DS-1150b; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under curve (AUC)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
maximum plasma concentration (Cmax)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
terminal elimination half-life (t1/2)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
time to reach maximum plasma concentration (Tmax)
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
Secondary outcomes (4)
measure the effects on Insulin and C-peptide Levels
To assess the effects of single oral dose of DS-1150b on insulin and C-peptide levels in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
number of patients experiencing adverse events
To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus.
Measured: 24 days, Day -5 to Day 19
measure the effects on glucagon Levels
To assess the effects of single oral dose of DS-1150b on glucagon levels in subjects with Type 2 Diabetes Mellitus.
Measured: 24 days, Day -5 to Day 19
number of patients experiencing laboratory adverse events
To assess the safety and tolerability of single oral dose of DS-1150b in subjects with Type 2 diabetes mellitus.
Measured: 24 days, Day -5 to Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2013
- Study completionOct 2013
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.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004678
- Sponsor's protocol ID
- DS1150-A-U101
- Status last verified
- Dec 2013
- First submitted
- 25 Oct 2013
- Last updated
- 24 Dec 2018
- 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 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Single-Blind, Placebo-Controlled, Randomized, Two-Part, Sequential, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02004678
- Acronym / sponsor ID
- DS1150-A-U101
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Dec 2013 (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.
DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus. This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of DS-1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, 7.5 mg DS-1150b | Other | Drug: DS-1150b, Other: PlaceboDosing will occur over two periods. Subjects will receive either * a dose of placebo in Period 1 followed by a single dose of 7.5 mg DS-1150b in Period 2; or * a single dose of 7.5 mg DS-1150b in Period 1 followed by a dose of placebo in Period 2. |
| Cohort 2, 15 mg DS-1150b | Other | Drug: DS-1150b, Other: PlaceboDosing will occur over two periods. Subjects will receive either * a dose of placebo in Period 1 followed by a single dose of 15 mg DS-1150b in Period 2; or * a single dose of 15 mg DS-1150b in Period 1 followed by a dose of placebo in Period 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- All women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. Women must be of non-childbearing potential, either:
- ≥40 mIU/mL.
- Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception (eg, an intrauterine device, diaphragm with spermicide, oral until 12 weeks following the last dose administration. In addition, the male subjects must not donate sperm after the study for a period of 12 weeks.
- Subjects must give written informed consent to participate in the study prior to screening.
- Subjects must be in good health as determined by screening medical history, physical examination findings, vital signs measurement, ECGs, serum chemistry, hematology, virology (ie, HIV, HBV, and HCV at screening only), and urinalysis performed at screening and on Day -1.
Key exclusion criteria (19 listed)
- History of gastrointestinal ulcer or erosion, or rhabdomyolysis within 6 months of dose administration.
- Subjects with laboratory results outside the normal range, if considered clinically significant by the Investigator.
- Subjects with serum K above the ULN of the clinical laboratory's reference range at screening and on Day -1.
- Subjects with CPK above the ULN at screening and on Day -1.
- Subjects with lactate above the ULN at screening and on Day -1.
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-1150b | Drug | Cohort 1, 7.5 mg DS-1150b, Cohort 2, 15 mg DS-1150b |
| Placebo | Other | Cohort 1, 7.5 mg DS-1150b, Cohort 2, 15 mg DS-1150b |
Primary outcome
area under curve (AUC)
Time frame: 24 days, Day -5 to Day 19
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
maximum plasma concentration (Cmax)
Time frame: 24 days, Day -5 to Day 19
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
terminal elimination half-life (t1/2)
Time frame: 24 days, Day -5 to Day 19
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
time to reach maximum plasma concentration (Tmax)
Time frame: 24 days, Day -5 to Day 19
To assess the effect of single oral doses of DS-1150b on glucose excursion (incremental glucose AUC0-3h) after an OGTT in subjects with Type 2 Diabetes Mellitus.
4 secondary outcomes
measure the effects on Insulin and C-peptide Levels
Time frame: 24 days, Day -5 to Day 19
number of patients experiencing adverse events
Time frame: 24 days, Day -5 to Day 19
measure the effects on glucagon Levels
Time frame: 24 days, Day -5 to Day 19
number of patients experiencing laboratory adverse events
Time frame: 24 days, Day -5 to Day 19
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 24 Dec 2018.
- 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 Phase 1 study testing DS-1150b in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 1 site in United States.
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 19 inclusion and 19 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 24 Dec 2018. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
area under curve (AUC) (time frame: 24 days, Day -5 to Day 19). The study lists 4 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 24 Dec 2018.