Diabetes Mellitus, Type 2Phase 2NCT00790660
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
A Phase 2 study testing ASP1941 in people with Diabetes Mellitus, Type 2, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ASP1941
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2008to 6 Mar 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of type 2 diabetes mellitus
- HbA1c value between 7.0 and 10.0%
- Body mass index between 20 and 45 kg/m2
Who cannot join
- Established diagnosis of type 1 diabetes mellitus
- Serum creatinine > upper limit of normal range
- Proteinuria (microalbumin/creatinine ratio > 300 mg/g)
- Urinary tract infection
- Severe uncontrolled Hypertension
- Significant renal, hepatic or cardiovascular disease
- HIV Positive
- History of drug or alcohol abuse/dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Read the detailed description
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ASP1941, Placebo
- Keywords
- ASP1941, 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.
ASP1941Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 Lowest Dose | Experimental | Oral Receives: Drug: ASP1941 |
| ASP1941 Low Dose | Experimental | Oral Receives: Drug: ASP1941 |
| ASP1941 Medium Dose | Experimental | Oral Receives: Drug: ASP1941 |
| ASP1941 High Dose | Experimental | Oral Receives: Drug: ASP1941 |
| Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety through clinical safety labs and adverse events
Measured: 6 Weeks
Secondary outcomes (1)
Evaluation of routine PK and PD parameters
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study start23 Oct 2008
- Primary completion6 Mar 2009
- Study completion6 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790660
- Sponsor's protocol ID
- 1941-CL-0016
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2008
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00790660
- Acronym / sponsor ID
- 1941-CL-0016
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- ASP1941, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2008 (actual)
- Primary completion
- 6 Mar 2009 (actual)
- Study completion
- 6 Mar 2009 (actual)
- First posted
- 13 Nov 2008 (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 study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus
Detailed description
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ASP1941 Lowest Dose | Experimental | Drug: ASP1941Oral |
| ASP1941 Low Dose | Experimental | Drug: ASP1941Oral |
| ASP1941 Medium Dose | Experimental | Drug: ASP1941Oral |
| ASP1941 High Dose | Experimental | Drug: ASP1941Oral |
| Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of type 2 diabetes mellitus
- HbA1c value between 7.0 and 10.0%
- Body mass index between 20 and 45 kg/m2
Key exclusion criteria (8 listed)
- Established diagnosis of type 1 diabetes mellitus
- Serum creatinine > upper limit of normal range
- Proteinuria (microalbumin/creatinine ratio > 300 mg/g)
- Urinary tract infection
- Severe uncontrolled Hypertension
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 |
|---|---|---|
| ASP1941Oral | Drug | ASP1941 High Dose, ASP1941 Low Dose, ASP1941 Lowest Dose, ASP1941 Medium Dose |
| PlaceboOral | Drug | Placebo |
Primary outcome
Evaluation of safety through clinical safety labs and adverse events
Time frame: 6 Weeks
1 secondary outcome
Evaluation of routine PK and PD parameters
Time frame: 6 Weeks
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 14 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
use Central Contact study director
Astellas Pharma Global Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP1941 in people with Diabetes Mellitus, Type 2, run by Astellas Pharma 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 3 inclusion and 8 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 14 Nov 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of safety through clinical safety labs and adverse events (time frame: 6 Weeks). 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 14 Nov 2024.