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Sitagliptin in Renal Transplant Recipients

Primary Purpose

Glucose Intolerance

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

sitagliptin

placebo

About this trial

This is an interventional treatment trial for Glucose Intolerance focused on measuring renal transplantation, diabetes, glucose intolerance, impaired glucose tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Renal transplant recipient more than 1 year posttransplant with stable renal function (less than 20% deviation in serum creatinine the last 2 months) and stable prednisolone dose for the last 3 months before inclusion.
Patients in need of (additional) oral anti-diabetic treatment:
- New onset diabetes patients with fasting plasma glucose 7-8 mmol/ l, and/or 2-hr plasma glucose 12-18 mmol/l after an oral glucose tolerance test (OGTT)
- Patients already on oral hypoglycemic therapy, but with HbA1c 8-11%
18 years of age.
Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
Signed informed consent.

Exclusion Criteria:

Treatment with insulin
Severe liver disease.
Estimated GFR < 25 ml/min/1.73 m2.
Skin disorders that may influence laser Doppler flowmetry investigations.
Pregnant or nursing mothers.

Sites / Locations

Rikshospitalet Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Patients will receive 4 weeks of treatment with sitagliptin once daily

No treatment for 4 weeks

Outcomes

Primary Outcome Measures

Insulin secretion

Secondary Outcome Measures

Insulin sensitivity

Fasting blood glucose

Endothelial function

Cyclosporine/tacrolimus blood concentrations

Full Information

NCT ID

NCT00740363

First Posted

August 21, 2008

Last Updated

September 21, 2012

Sponsor

University of Oslo School of Pharmacy

Collaborators

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00740363

Brief Title

Sitagliptin in Renal Transplant Recipients

Official Title

The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oslo School of Pharmacy

Collaborators

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The major cause of premature death in renal transplant recipients is cardiovascular disease. Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug for the treatment of posttransplant diabetes mellitus in transplanted patients. The primary objective of the present study is to investigate the effect of sitagliptin on insulin secretion in renal transplant recipients. Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose, endothelial function, CsA/Tac blood concentrations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glucose Intolerance

Keywords

renal transplantation, diabetes, glucose intolerance, impaired glucose tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients will receive 4 weeks of treatment with sitagliptin once daily

Arm Title

Arm Type

Placebo Comparator

Arm Description

No treatment for 4 weeks

Intervention Type

Drug

Intervention Name(s)

sitagliptin

Other Intervention Name(s)

Januvia

Intervention Description

Once daily sitagliptin. If GFR>50 ml/min/1.73m2: 100 mg/day. If GFR from 25 to 49 ml/min/1.3m2: 50 mg/day

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

No active sitagliptin treatment for 4 weeks

Primary Outcome Measure Information:

Title

Insulin secretion

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Insulin sensitivity

Time Frame

4 weeks

Title

Fasting blood glucose

Time Frame

4 weeks

Title

Endothelial function

Time Frame

4 weeks

Title

Cyclosporine/tacrolimus blood concentrations

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Renal transplant recipient more than 1 year posttransplant with stable renal function (less than 20% deviation in serum creatinine the last 2 months) and stable prednisolone dose for the last 3 months before inclusion. Patients in need of (additional) oral anti-diabetic treatment: New onset diabetes patients with fasting plasma glucose 7-8 mmol/ l, and/or 2-hr plasma glucose 12-18 mmol/l after an oral glucose tolerance test (OGTT) Patients already on oral hypoglycemic therapy, but with HbA1c 8-11% 18 years of age. Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs. Signed informed consent. Exclusion Criteria: Treatment with insulin Severe liver disease. Estimated GFR < 25 ml/min/1.73 m2. Skin disorders that may influence laser Doppler flowmetry investigations. Pregnant or nursing mothers.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trond Jenssen, MD, Professor

Organizational Affiliation

Rikshospitalet Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rikshospitalet Medical Center

City

Oslo

ZIP/Postal Code

0027

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

32803882

Citation

Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

Results Reference

derived

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Sitagliptin in Renal Transplant Recipients

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