Type 2 Diabetes MellitusPhase 1NCT01042106
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
A Phase 1 study testing DSP-8658 in people with Type 2 Diabetes Mellitus, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DSP-8658
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≤45
- Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≥ 18 and ≤ 29
- Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.
Who cannot join
- Have a current or expected requirement for any antidiabetic or lipid-lowering drug
- Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DSP-8658, Placebo
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-8658Drug
Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
PlaceboDrug
Placebo 2.5, 10, 20, 40 mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| DSP-8658 | Experimental | DSP-8658 2.5, 10, 20, 40 mg once daily Receives: Drug: DSP-8658 |
| Placebo | Placebo comparator | Placebo 2.5, 10, 20, and 40 mg doses once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments include physical examination, laboratory variables and ECG.
Measured: 20 days
Secondary outcomes (2)
Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study.
Measured: 20 days
Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042106
- Sponsor's protocol ID
- D6950153
- Status last verified
- Sep 2013
- First submitted
- 21 Dec 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01042106
- Acronym / sponsor ID
- D6950153
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Jan 2010 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSP-8658 | Experimental | Drug: DSP-8658DSP-8658 2.5, 10, 20, 40 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2.5, 10, 20, and 40 mg doses once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≤45
- Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug
- Age ≥ 18 and ≤ 65 years
- Body Mass Index ≥ 18 and ≤ 29
Key exclusion criteria (2 listed)
- Have a current or expected requirement for any antidiabetic or lipid-lowering drug
- Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
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 |
|---|---|---|
| DSP-8658Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily | Drug | DSP-8658 |
| PlaceboPlacebo 2.5, 10, 20, 40 mg orally once daily | Drug | Placebo |
Primary outcome
Safety assessments include physical examination, laboratory variables and ECG.
Time frame: 20 days
2 secondary outcomes
Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study.
Time frame: 20 days
Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study.
Time frame: 18 days
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 16 Sep 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.
Medical Director, MD study director
Sumitomo Pharma America, Inc.
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 DSP-8658 in people with Type 2 Diabetes Mellitus, run by Sumitomo Pharma America, Inc. 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 6 inclusion and 2 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 16 Sep 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?
Safety assessments include physical examination, laboratory variables and ECG. (time frame: 20 days). 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 16 Sep 2013.