Type 2 Diabetes MellitusPhase 1NCT01862939
A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
A Phase 1 study testing DS-7309 in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study. Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DS-7309
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women must be of non-child bearing potential, ie, either:
- Surgically sterile (ie, bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing), or
- Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at screening of ≥ 40 mIU/mL.
- All women must have a negative serum pregnancy test at screening and within 48 hours before dosing.
- Able to understand and willing to comply with all study requirements, and willing to follow the study medication regimen.
- Subjects must give written informed consent to participation in the study prior to screening.
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- Negative urine test for drugs of abuse and alcohol at screening and check-in.
- Negative result for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody at screening.
- Subjects must agree to abstain from alcohol, cola, tea, coffee, chocolate and other caffeinated drink and food from 2 days before check-in and throughout confinement.
- Subjects must agree to abstain from grapefruit/grapefruit juice and Seville oranges from 10 days before the first dose and throughout the study.
- Healthy women who are not of childbearing potential and men, 18 to 45 years of age, inclusive.
- Body Mass Index (BMI) of 19.00 to 32.00 kg/m2 inclusive.
- Good health, as determined by the absence of clinically significant deviation from normal, based on medical history, physical examination, laboratory reports, and 12-lead ECG, as deemed by the Investigator, prior to enrollment.
- Baseline (0 hour) pre-dose capillary blood glucose ≥ 70 mg/dL. Part 2 (T2DM subjects)
- Women who are not of childbearing potential and men, 18 to 55 years of age, inclusive.
- Diagnosis of type 2 diabetes mellitus for a minimum of 3 months prior to first dose.
- Body Mass Index (BMI) of 19.00 to 40.00 kg/m2 inclusive.
- Subjects should be either:
- Treatment naïve from any antidiabetic treatment for at least 6 months prior to screening with a hemoglobin A1c (HBA1c) value between 7%-10%, inclusive.
- On metformin alone with a HBA1c value between 7%-9%, inclusive, and willing to discontinue current metformin treatment for at least 2 weeks prior to study and during the duration of the study. See Section 9.10.1 for monitoring during 2 week washout.
Who cannot join
- Female subject is of childbearing potential, is pregnant (as based on test results) or is breast feeding.
- Male subjects should ensure use of condom and spermicide from dosing until 12 weeks after dosing.
- Male subjects must agree not to donate sperm from dosing until 12 weeks after dosing.
- Any history of drug abuse.
- History of alcohol addiction during the 2 years prior to Day 1.
- History or current evidence, as determined by the Investigator, of psychiatric or emotional problems which would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
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- History or current alcoholic or non-alcoholic liver disease or liver steatosis.
- History of neuropathy.
- Subjects with QTcF interval duration >450 msec obtained from the ECG taken at screening, after at least 10 minutes of quiet rest in a supine position.
- Subjects with a family history of long QT syndrome.
- Subjects with any history of arrhythmia.
- Significant blood donation or significant blood loss within the 56 days before Day -1.
- Plasma donation within 7 days before Day -1.
- Participation in another investigational new drug research study within the 30 days before Day 1.
- Use of tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within the 6 months before Day 1.
- Relationship of the subject to the Investigator, any sub-investigator, pharmacist, study coordinator, or other staff directly involved in the conduct of the study, or employment by the Sponsor or contract research organization participating in the study.
- Familial relationship of the subject to any subjects previously or currently enrolled in the study.
- Screening laboratory values outside the range of normal values that are deemed clinically significant by the Investigator. Liver function tests (AST, ALT, total bilirubin, and lactate dehydrogenase [LDH]) must be at or below the ULN. If a subject has a non-clinically significant high abnormal reading for one or more of the liver function tests on the screening lab test, the test may be repeated once. If the lab test results are normal on the repeat test, he/she may be enrolled provided the Day -1 lab test results are also normal.
- Hemoglobin levels below the lower limit of normal of the clinical laboratory's reference range at the screening visit.
- Enrollment in a prior dose cohort of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo-Controlled, Randomized, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.
Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DS-7309, 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.
DS-7309Drug
1, 2.5, 5, 10, 20 mg DS-7309 powder in bottle.
placeboDrug
placebo to match part 2 DS-7309
| Study group | Role | What they receive |
|---|---|---|
| part 1 DS-7309 ascending dose | Experimental | 1, 2.5, 5, 10, 20 mg blinded DS-7309 powder in bottle. Receives: Drug: DS-7309 |
| part 2 DS-7309 | Experimental | 1, 2.5, 5, and 15mg DS-7309 powder in bottle for oral solution. Receives: Drug: DS-7309 |
| part 2 placebo | Placebo comparator | placebo to match part 2 DS-7309 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental area under the curve (IAUC) blood glucose
The incremental area under the curve (IAUC) of the PD biomarker blood glucose following an oral glucose tolerance test (OGTT) in subjects with type 2 diabetes mellitus (T2DM).
Measured: 5 hours
Secondary outcomes (1)
determine blood concentrations of DS-7309
The plasma pharmacokinetic (PK) parameters of A203-5319 (the free form of DS-7309) and relevant metabolite of DS-7309 in healthy subjects and subjects with T2DM.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 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
- NCT01862939
- Sponsor's protocol ID
- DS7309-A-U101
- Status last verified
- May 2013
- First submitted
- 22 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Randomized, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01862939
- Acronym / sponsor ID
- DS7309-A-U101
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 May 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.
This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.
Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| part 1 DS-7309 ascending dose | Experimental | Drug: DS-73091, 2.5, 5, 10, 20 mg blinded DS-7309 powder in bottle. |
| part 2 DS-7309 | Experimental | Drug: DS-73091, 2.5, 5, and 15mg DS-7309 powder in bottle for oral solution. |
| part 2 placebo | Placebo comparator | Drug: placeboplacebo to match part 2 DS-7309 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Women must be of non-child bearing potential, ie, either:
- All women must have a negative serum pregnancy test at screening and within 48 hours before dosing.
- Able to understand and willing to comply with all study requirements, and willing to follow the study medication regimen.
- Subjects must give written informed consent to participation in the study prior to screening.
- Negative urine test for drugs of abuse and alcohol at screening and check-in.
Key exclusion criteria (20 listed)
- Female subject is of childbearing potential, is pregnant (as based on test results) or is breast feeding.
- Male subjects should ensure use of condom and spermicide from dosing until 12 weeks after dosing.
- Male subjects must agree not to donate sperm from dosing until 12 weeks after dosing.
- Any history of drug abuse.
- History of alcohol addiction during the 2 years prior to 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-73091, 2.5, 5, 10, 20 mg DS-7309 powder in bottle. | Drug | part 1 DS-7309 ascending dose, part 2 DS-7309 |
| placeboplacebo to match part 2 DS-7309 | Drug | part 2 placebo |
Primary outcome
incremental area under the curve (IAUC) blood glucose
Time frame: 5 hours
The incremental area under the curve (IAUC) of the PD biomarker blood glucose following an oral glucose tolerance test (OGTT) in subjects with type 2 diabetes mellitus (T2DM).
1 secondary outcome
determine blood concentrations of DS-7309
Time frame: 48 hours
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 27 May 2013.
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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-7309 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 20 inclusion and 20 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 27 May 2013. 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. 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 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?
incremental area under the curve (IAUC) blood glucose (time frame: 5 hours). 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 27 May 2013.