NCT00418366

Brief Summary

A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

January 3, 2007

Last Update Submit

August 18, 2015

Conditions

Renal InsufficiencyHemodialysis

Keywords

Mild, moderate, severe renal insufficiencyEnd stage renal disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MK0431, sitagliptin phosphate / Duration of Treatment : 1 DaysDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17468348RESULT

MeSH Terms

Conditions

Renal InsufficiencyLymphoma, FollicularKidney Failure, Chronic

Interventions

Sitagliptin PhosphateDuration of Therapy

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

January 1, 2003

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

August 19, 2015

Record last verified: 2015-08