Type 2 Diabetes MellitusPhase 1NCT01956305
Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study
A Phase 1 study testing DS-7309 and Metformin in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 1 site in United States.
Trial summary
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DS-7309 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers aged 18 to 65 years, inclusive.
- 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
- Women must be of non-childbearing potential
- Diagnosed with T2DM for at least 3 months prior to first dose.
- Subjects must be either:
- On monotherapy with either metformin or a DPP-IV inhibitor alone with a HbA1c between 6.5% to 9.5%, inclusive, and willing to discontinue current metformin or DPP-IV inhibitor treatment for at least 2 weeks prior to check in and until discharge from the clinic (for Cohorts A to E). OR Treatment naive from any anti-diabetes mellitus drugs for at least 3 months prior to Screening with an HbA1c between 7% to 10%, inclusive.
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- Fasting plasma glucose ≥100 mg/dL and ≤250 mg/dL at Screening.
- Fasting plasma glucose ≥120 mg/dL and ≤250 mg/dL on Day -6.
- All women must have a negative serum pregnancy test at Screening and within 2 days before dosing.
- A BMI of 19 to 36 kg/m2 inclusive; or, if outside the range, not clinically significant and agreed upon by DSPD or the CRO and the Investigator.
- Good health as determined by the absence of clinically significant deviations from normal, based on medical history, physical examination, laboratory reports, and triplicate 12-lead ECG (except for findings associated with T2DM), as deemed by the Investigator, prior to enrollment.
- Has given written informed consent prior to participating in the study.
- Able to understand and willing to comply with all study requirements, and willing to allow the collection of all blood and urine specimens.
- Negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, phencyclidine), cotinine, and alcohol at Screening.
- Negative result for HIV antibody hepatitis B surface antigen, and hepatitis C antibody at Screening.
- Willing to abstain from grapefruit/grapefruit juice and Seville oranges from 10 days before the first dose and throughout the study.
- Willing to refrain from consuming food or beverages containing caffeine/xanthine starting 24 hours prior to check-in.
Who cannot join
- History of type 1 diabetes and/or history of diabetic ketoacidosis.
- History or clinical and laboratory evidence of significant complications of T2DM, including proliferative retinopathy, macroalbuminuria, peripheral neuropathy, ischemic heart disease, stroke, and peripheral vascular disease.
- Screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator. Liver function tests (AST, ALT, total bilirubin) and lactate dehydrogenase must be at or below 1.5 times ULN. If a subject has a non-clinically significant high abnormal reading for 1 or more of the liver function test results that are at or below 1.5 times ULN on the repeat test, the subject may be enrolled provided the results from the laboratory tests performed on the day after check-in are also at or below 1.5 times ULN.
- Estimated glomerular filtration rate (eGFR) <80 mL/min.
- Any history of drug abuse.
- History of alcohol addiction during the 2 years prior to Screening.
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- History of significant allergic response to any drug except penicillin.
- History or current evidence, as determined by the Investigator, of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
- History or current evidence of clinically significant cardiac, hepatic, renal, urinary, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by the Investigator.
- Subjects with a history of congenital long QT syndrome, a history of surviving a near-drowning episode, or a history of unexplained syncope or loss of consciousness.
- Subjects with QTcF interval duration > 450 msec obtained as an average from the ECG machine readings on the triplicate ECG taken at Screening.
- Subjects with abnormal ECG waveform morphology on any of the ECGs from the screening triplicate that would preclude accurate manual measurement of the QT interval duration.
- Hemoglobin < 12.0 g/dL at Screening.
- Need for any concomitant medication except for those specified Consumption of foods or beverages containing alcohol from 24 hours before check-in through discharge from the clinic.
- Blood donation of 500 mL or more or significant blood loss within the 56 days before check-in.
- Plasma donation within 7 days before check-in.
- Participation in another investigational new drug research study within the 30 days before check-in.
- Use of tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within the 6 months before check-in.
- 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 DSPD or the CRO participating in the study.
- Familial relationship of the subject to any subjects previously or currently enrolled in the study.
- Enrollment in a prior dose cohort of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, (Subject and Investigator Blinded, Sponsor Unblinded), Two-Period, Placebo-Controlled, Randomized, Sequential, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS 7309 In Subjects With Type 2 Diabetes Mellitus
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.
Read the detailed description
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, single-blind (subject and investigator-blinded, sponsor-unblinded), sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of multiple doses of DS-7309 in subjects with T2DM. The safety and tolerability of each new dose level will be tested in a single day administration prior to start of repeated dosing.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DS-7309, placebo, Metformin
- 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
DS-7309 powder in bottle
placeboDrug
placebo to match DS-7309 powder in bottle
MetforminDrug
Metformin 500mg tablet for Cohort F
| Study group | Role | What they receive |
|---|---|---|
| Cohort A 10mg DS-7309 | Experimental | DS-7309 10 mg twice daily Receives: Drug: DS-7309 |
| Cohort B 20mg DS-7309 | Experimental | DS-7309 20 mg twice daily Receives: Drug: DS-7309 |
| Cohort C DS-7309 40 mg | Experimental | DS-7309 40 mg twice daily Receives: Drug: DS-7309 |
| Cohort D DS-7309 75 mg | Experimental | DS-7309 75 mg twice daily Receives: Drug: DS-7309 |
| Cohort E DS-7309 150 mg | Experimental | DS-7309 150 mg twice daily Receives: Drug: DS-7309 |
| Cohort F DS-7309 150 mg with escalating metformin doses | Experimental | DS-7309 150 mg twice daily with escalating metformin doses Receives: Drug: DS-7309; Drug: Metformin |
| Placebo | Placebo comparator | placebo to match DS-7309 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of DS-7309
number, type and severity of adverse events
Measured: 23 days, Day -7 through Day 16
determine the pharmacokinetics of DS-7309 after repeated doses
Cmax, Tmax, area under the concentration curve (AUC)
Measured: 23 days, Day-7 through Day 16
determine glycemic response
glycemic response will be assessed by blood sampling for plasma glucose after a meal tolerance test and from 24h weighted mean glucose on Day -1 and Day 12
Measured: 23 days, Day -7 through Day 16
Secondary outcomes (6)
To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects
To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects
Measured: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on blood pressure
To assess the effects of repeated doses of DS-7309 on blood pressure (by means of 24 h ambulatory blood pressure measurements (ABPMs)
Measured: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on lipid profile
To assess the effects of repeated doses of DS-7309 on lipid profile (total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol and triglycerides)
Measured: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on plasma lactate levels
To assess the effects of repeated doses of DS-7309 on plasma lactate levels
Measured: 23 days; Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects
To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects
Measured: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on glucagon levels in T2DM subjects
To assess the effects of repeated doses of DS-7309 on glucagon levels in T2DM subjects
Measured: 23 days, Day -7 through Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 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
- NCT01956305
- Sponsor's protocol ID
- DS7309-A-U102
- Status last verified
- Nov 2014
- First submitted
- 30 Sep 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, (Subject and Investigator Blinded, Sponsor Unblinded), Two-Period, Placebo-Controlled, Randomized, Sequential, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS 7309 In Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01956305
- Acronym / sponsor ID
- DS7309-A-U102
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Oct 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-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.
Detailed description
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, single-blind (subject and investigator-blinded, sponsor-unblinded), sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of multiple doses of DS-7309 in subjects with T2DM. The safety and tolerability of each new dose level will be tested in a single day administration prior to start of repeated dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A 10mg DS-7309 | Experimental | Drug: DS-7309DS-7309 10 mg twice daily |
| Cohort B 20mg DS-7309 | Experimental | Drug: DS-7309DS-7309 20 mg twice daily |
| Cohort C DS-7309 40 mg | Experimental | Drug: DS-7309DS-7309 40 mg twice daily |
| Cohort D DS-7309 75 mg | Experimental | Drug: DS-7309DS-7309 75 mg twice daily |
| Cohort E DS-7309 150 mg | Experimental | Drug: DS-7309DS-7309 150 mg twice daily |
| Cohort F DS-7309 150 mg with escalating metformin doses | Experimental | Drug: DS-7309, Drug: MetforminDS-7309 150 mg twice daily with escalating metformin doses |
| Placebo | Placebo comparator | Drug: placeboplacebo to match DS-7309 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female volunteers aged 18 to 65 years, inclusive.
- 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
- Women must be of non-childbearing potential
- Diagnosed with T2DM for at least 3 months prior to first dose.
- Subjects must be either:
Key exclusion criteria (21 listed)
- History of type 1 diabetes and/or history of diabetic ketoacidosis.
- History or clinical and laboratory evidence of significant complications of T2DM, including proliferative retinopathy, macroalbuminuria, peripheral neuropathy, ischemic heart disease, stroke, and peripheral vascular disease.
- Screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator. Liver function tests (AST, ALT, total bilirubin) and lactate dehydrogenase must be at or below 1.5 times ULN. If a subject has a non-clinically significant high abnormal reading for 1 or more of the liver function test results that are at or below 1.5 times ULN on the repeat test, the subject may be enrolled provided the results from the laboratory tests performed on the day after check-in are also at or below 1.5 times ULN.
- Estimated glomerular filtration rate (eGFR) <80 mL/min.
- Any history of drug abuse.
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-7309DS-7309 powder in bottle | Drug | Cohort A 10mg DS-7309, Cohort B 20mg DS-7309, Cohort C DS-7309 40 mg, Cohort D DS-7309 75 mg, Cohort E DS-7309 150 mg, Cohort F DS-7309 150 mg with escalating metformin doses |
| placeboplacebo to match DS-7309 powder in bottle | Drug | Placebo |
| MetforminMetformin 500mg tablet for Cohort F | Drug | Cohort F DS-7309 150 mg with escalating metformin doses |
Primary outcome
safety and tolerability of DS-7309
Time frame: 23 days, Day -7 through Day 16
number, type and severity of adverse events
determine the pharmacokinetics of DS-7309 after repeated doses
Time frame: 23 days, Day-7 through Day 16
Cmax, Tmax, area under the concentration curve (AUC)
determine glycemic response
Time frame: 23 days, Day -7 through Day 16
glycemic response will be assessed by blood sampling for plasma glucose after a meal tolerance test and from 24h weighted mean glucose on Day -1 and Day 12
6 secondary outcomes
To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects
Time frame: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on blood pressure
Time frame: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on lipid profile
Time frame: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on plasma lactate levels
Time frame: 23 days; Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects
Time frame: 23 days, Day -7 through Day 16
To assess the effects of repeated doses of DS-7309 on glucagon levels in T2DM subjects
Time frame: 23 days, Day -7 through Day 16
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 Nov 2014.
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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 and Metformin 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 17 inclusion and 21 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 Nov 2014. 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?
safety and tolerability of DS-7309 (time frame: 23 days, Day -7 through Day 16). The study lists 3 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 Nov 2014.