Renal InsufficiencyPhase 1NCT00418366
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
A Phase 1 study testing MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days in people with Renal Insufficiency and Hemodialysis, run by Merck Sharp & Dohme LLC.
Trial summary
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Hemodialysis
- What is being tested?
- MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Mar 2003
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
- A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
- Smokes less than 10 cigarettes/day
Who cannot join
- Patients with uncontrolled diabetes or uncontrolled congestive heart failure
- Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
- Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
- Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg
About this study
Official title: An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
- Conditions
- Renal Insufficiency, Hemodialysis
- Being tested
- MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days
- Keywords
- Mild, moderate, severe renal insufficiency, End stage renal disease
- Medical subject headings
- Renal Insufficiency, Lymphoma, Follicular, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0431, sitagliptin phosphate / Duration of Treatment : 1 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
Secondary outcomes (1)
Safety and tolerability in patients with renal insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2003
- Primary completionMar 2003
- Study completionMar 2003
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 Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418366
- Sponsor's protocol ID
- 0431-008
- Other IDs
- 2006_562
- Status last verified
- Aug 2015
- First submitted
- 3 Jan 2007
- Last updated
- 19 Aug 2015
- Results posted
- No
Publications
Bergman AJ, Cote J, Yi B, Marbury T, Swan SK, Smith W, Gottesdiener K, Wagner J, Herman GA. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007 Jul;30(7):1862-4. doi: 10.2337/dc06-2545. Epub 2007 Apr 27. No abstract available.
PubMed 17468348
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00418366
- Acronym / sponsor ID
- 0431-008
- Conditions
- Renal Insufficiency, Hemodialysis
- Keywords
- Mild, moderate, severe renal insufficiency, End stage renal disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 4 Jan 2007 (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 evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
- A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
- Smokes less than 10 cigarettes/day
Key exclusion criteria (4 listed)
- Patients with uncontrolled diabetes or uncontrolled congestive heart failure
- Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
- Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
- Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg
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 |
|---|---|---|
| MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days | Drug | – |
Primary outcome
Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
1 secondary outcome
Safety and tolerability in patients with renal insufficiency
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 19 Aug 2015.
- Results publication: PubMed 17468348Bergman AJ, Cote J, Yi B, Marbury T, Swan SK, Smith W, Gottesdiener K, Wagner J, Herman GA. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007 Jul;30(7):1862-4. doi: 10.2337/dc06-2545. Epub 2007 Apr 27. No abstract available.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days in people with Renal Insufficiency and Hemodialysis, run by Merck Sharp & Dohme LLC.
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 4 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers. 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 NCT00418366, 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 19 Aug 2015.