Type 2 Diabetes MellitusPhase 1NCT01302028
Renal Impairment Study With ASP1941
A Phase 1 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 5 sites in 4 countries.
Trial summary
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- 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
- 40 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 22 Jan 2010to 26 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with stable type 2 diabetes mellitus or healthy subject
- Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
- >90 (normal renal function)
- 60-90 (mild renal impairment)
- 30-60 (moderate renal impairment)
- 15-30 (severe renal impairment)
- BMI between 25.0-40.0 kg/m2, inclusive
- Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)
Who cannot join
- Patients with Type 1 diabetes
- Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
- T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
- Healthy Volunteers: Any of the liver function tests above the upper limit of normal
- T2DM: The liver function tests should be within the following ranges:
- AST/ALT: <2 x ULN
Show all 13Show fewer
- Bilirubin: <1.5 x ULN
- Alk Phos: < 1.5 x ULN
- Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
- Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
- Patients with T2DM treated with a diet only
- T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose < 3mmol/l (<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
- T2DM patients with a Hemoglobin value < 9 g/dl (5.6 mmol/l)
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: An Open-label, Parallel Group Study to Assess the Effect of Different Grades of Renal Impairment in Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics and Safety & Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus With Normal Renal Function and Healthy Volunteers
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ASP1941
- Keywords
- Renal Impairment, ASP1941, Pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
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 |
|---|---|---|
| Healthy volunteers with normal renal function | Active comparator | Oral Receives: Drug: ASP1941 |
| T2DM patient with normal renal function | Experimental | Oral Receives: Drug: ASP1941 |
| T2DM patient with mild renal impairment | Experimental | Oral Receives: Drug: ASP1941 |
| T2DM patient with moderate renal impairment | Experimental | Oral Receives: Drug: ASP1941 |
| T2DM patient with severe renal impairment | Experimental | Oral Receives: Drug: ASP1941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
Measured: 5 days
Secondary outcomes (2)
Effect of grade of renal impairment on the pharmacodynamics of ASP1941
Measured: 5 days
Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study start22 Jan 2010
- Primary completion26 Jun 2010
- Study completion26 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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 Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302028
- Sponsor's protocol ID
- 1941-CL-0064
- Other IDs
- 2009-011320-61, 2009
- Status last verified
- Aug 2017
- First submitted
- 21 Feb 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrannini E, Veltkamp SA, Smulders RA, Kadokura T. Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes. Diabetes Care. 2013 May;36(5):1260-5. doi: 10.2337/dc12-1503. Epub 2013 Jan 28.
PubMed 23359360
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel Group Study to Assess the Effect of Different Grades of Renal Impairment in Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics and Safety & Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus With Normal Renal Function and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01302028
- Acronym / sponsor ID
- 1941-CL-0064
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Renal Impairment, ASP1941, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2010 (actual)
- Primary completion
- 26 Jun 2010 (actual)
- Study completion
- 26 Jun 2010 (actual)
- First posted
- 23 Feb 2011 (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.
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers with normal renal function | Active comparator | Drug: ASP1941Oral |
| T2DM patient with normal renal function | Experimental | Drug: ASP1941Oral |
| T2DM patient with mild renal impairment | Experimental | Drug: ASP1941Oral |
| T2DM patient with moderate renal impairment | Experimental | Drug: ASP1941Oral |
| T2DM patient with severe renal impairment | Experimental | Drug: ASP1941Oral |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with stable type 2 diabetes mellitus or healthy subject
- Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
- BMI between 25.0-40.0 kg/m2, inclusive
- Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)
Key exclusion criteria (13 listed)
- Patients with Type 1 diabetes
- Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
- T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
- Healthy Volunteers: Any of the liver function tests above the upper limit of normal
- T2DM: The liver function tests should be within the following ranges:
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 | Healthy volunteers with normal renal function, T2DM patient with mild renal impairment, T2DM patient with moderate renal impairment, T2DM patient with normal renal function, T2DM patient with severe renal impairment |
Primary outcome
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
Time frame: 5 days
2 secondary outcomes
Effect of grade of renal impairment on the pharmacodynamics of ASP1941
Time frame: 5 days
Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG
Time frame: 5 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 22 Aug 2017.
- Derived from this study: PubMed 23359360Ferrannini E, Veltkamp SA, Smulders RA, Kadokura T. Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes. Diabetes Care. 2013 May;36(5):1260-5. doi: 10.2337/dc12-1503. Epub 2013 Jan 28.
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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 Europe B.V.
5 sites in 4 countries: 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 5 sites in 4 countries.
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 8 inclusion and 13 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, Hungary, Poland, Slovakia. 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?
Effect of grade of renal impairment on the pharmacokinetics of ASP1941 (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302028, which also lists 1 linked publication.
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 22 Aug 2017.