Type 2 Diabetes MellitusPhase 1NCT01097681
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
A Phase 1 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ASP1941
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesJapan
- Study dates
- 16 Feb 2010to 18 Jun 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients for at least 12 weeks
- Fasting plasma glucose level of < 240 mg/dL
- Body Mass Index ( BMI )20.0 - 35.0kg/m2
- GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
Who cannot join
- Type 1 diabetes mellitus patients
- Receiving insulin within 12 weeks before screening
- Diabetic ketoacidosis
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ASP1941
- Keywords
- Urinary glucose excretion, Diabetes mellitus, ASP1941
- 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.
ASP1941Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function group | Experimental | oral Receives: Drug: ASP1941 |
| Mild renal impairment group | Experimental | oral Receives: Drug: ASP1941 |
| Moderate renal impairment group | Experimental | oral Receives: Drug: ASP1941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of ASP1941
Measured: For 72 hours after dosing
Secondary outcomes (3)
Urinary levels of ASP1941
Measured: For 72 hours after dosing
Urinary glucose excretion
Measured: For 72 hours after dosing
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
Measured: For 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study start16 Feb 2010
- Primary completion18 Jun 2010
- Study completion18 Jun 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097681
- Sponsor's protocol ID
- 1941-CL-0073
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2010
- Last updated
- 12 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
- ClinicalTrials.gov ID
- NCT01097681
- Acronym / sponsor ID
- 1941-CL-0073
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Urinary glucose excretion, Diabetes mellitus, ASP1941
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2010 (actual)
- Primary completion
- 18 Jun 2010 (actual)
- Study completion
- 18 Jun 2010 (actual)
- First posted
- 2 Apr 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 primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function group | Experimental | Drug: ASP1941oral |
| Mild renal impairment group | Experimental | Drug: ASP1941oral |
| Moderate renal impairment group | Experimental | Drug: ASP1941oral |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetic patients for at least 12 weeks
- Fasting plasma glucose level of < 240 mg/dL
- Body Mass Index ( BMI )20.0 - 35.0kg/m2
- GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus patients
- Receiving insulin within 12 weeks before screening
- Diabetic ketoacidosis
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
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 | Mild renal impairment group, Moderate renal impairment group, Normal renal function group |
Primary outcome
Plasma concentration of ASP1941
Time frame: For 72 hours after dosing
3 secondary outcomes
Urinary levels of ASP1941
Time frame: For 72 hours after dosing
Urinary glucose excretion
Time frame: For 72 hours after dosing
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
Time frame: For 72 hours after dosing
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 12 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 chair
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 2 sites in Japan.
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 4 inclusion and 6 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 12 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 2 sites in Japan. 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?
Plasma concentration of ASP1941 (time frame: For 72 hours after dosing). 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 12 Nov 2024.