NCT00936663

Brief Summary

This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 25, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

July 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

April 24, 2018

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 25, 2009

Results QC Date

February 8, 2018

Last Update Submit

August 21, 2023

Conditions

Type 2 DiabetesEnd Stage Renal Disease

Keywords

DiabetesKidney TransplantSitagliptin

Outcome Measures

Primary Outcomes (1)

  • Fasting Blood Glucose

    Fasting blood glucose levels at 1 year

    1 year

Secondary Outcomes (3)

  • HbA1c

    1 year

  • eGFR

    1 year

  • Hypoglycemia

    1 year

Other Outcomes (4)

  • AUC for Glucose

    1 year

  • AUC for Insulin

    1 year

  • AUC for Proinsulin

    1 year

  • +1 more other outcomes

Study Arms (2)

Sitagliptin 100 mg daily

EXPERIMENTAL

sitagliptin 100 mg daily

Drug: Sitagliptin

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

PlaceboDRUG

Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.

placebo
SitagliptinDRUG

Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.

Sitagliptin 100 mg daily

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of a kidney transplant at UNMC, including cadaveric or living donor transplant.

You may not qualify if:

  • A previous diagnosis of diabetes or previous criteria for diabetes, according to the American Diabetes Association, not previously recognized as diabetes.
  • Simultaneous transplant of another solid organ, such liver or heart.
  • Patient unable to take oral medication.
  • Patient unable to give informed consent.
  • Hypersensitivity to sitagliptin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

  • Lane JT, Odegaard DE, Haire CE, Collier DS, Wrenshall LE, Stevens RB. Sitagliptin therapy in kidney transplant recipients with new-onset diabetes after transplantation. Transplantation. 2011 Nov 27;92(10):e56-7. doi: 10.1097/TP.0b013e3182347ea4. No abstract available.

    PMID: 22067216BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Kidney Failure, ChronicDiabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Limitations and Caveats

We did not reach the target number of participants needed to achieve target power and statistically reliable results as the funding was not renewed by the sponsor.

Results Point of Contact

Title
Vijay Shivaswamy
Organization
University of Nebraska Medical Center
vshivaswamy@unmc.edu
402-559-6208

Study Officials

  • Vijay Shivaswamy, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

July 10, 2009

Study Start

July 6, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

September 13, 2023

Results First Posted

April 24, 2018

Record last verified: 2023-08

Locations

US(1)