Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant

This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Kidney Transplant
• Intervention / Treatment: Drug: Administration of sitagliptin

Detailed Description

Within the last six months, the FDA has approved sitagliptin phosphate as an oral drug that potentiates the effect of native GLP-1 through inhibition of DPP-4. It is approved for treatment of type 2 diabetes in adults as monotherapy or in combination with metformin or a TZD. It has several advantages over extenatide when considering its use in kidney transplant recipients:

1. It is administered orally once a day
2. Nausea occurred at a rate of only 1.4%
3. Its potential of hypoglycemia is low

However, it may not be as potent, in terms of HbA1C with % change in HbA1C<1%. In addition there is not a lot of information on gastric emptying, although this is probably not as severe as exenatide, with fewer symptoms of nausea reported.

We propose to conduct a pilot study for using sitagliptin in patients who have both type 2 diabetes and who have received a kidney transplant. Our objectives are to study the effect of sitagliptin administration on side effect profiles, change in HbA1C, and the percentage of patients who require discontinuation of the drug as a result of major changes in immunosuppressant drug levels. The data will be used as preliminary data for a larger study that attempts to prevent or delay the onset of PTDM in kidney transplant recipients. We anticipate treating patients with both impaired fasting glucose and normoglycemia, given the high frequency of PTDM in the post-kidney transplant population.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-1230
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 Diabetes Mellitus
• Most recent HbA1C 6.5-10%
• 1 year post kidney transplant

Exclusion Criteria:

• Patients treated primarily with insulin for their diabetes
• Kidney allograft not functional at entry or estimated creatinine clearance of <30 ml/min
• Clinical course complicated by persistent nausea
• severe gastroparesis
• Severe recurrent hypoglycemia (>1 hypoglycemic episode requiring the help of another person per week).
• Patients on dialysis therapy
• Unstable renal function in the preceding 3 months
• Serum transaminases >2 times normal at study entry
• Smokers
• Pregnant or planning to become pregnant
• Lactating
• Recipients of multi-organ transplants
• Unstable medical conditions which result in multiple hospitalizations or a severely restricted lifestyle
• Hemoglobin <10.0g/dl
• Use of digoxin
• Patients receiving their primary care outside of UNMC
• Inability to come to follow-up visits as a part of the protocol
• Patients not taking tacrolimus and sarolimus as part of their immunosuppressive therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Administration of sitagliptin; Sitagliptin 100 mg daily for 3 months; Other Names: Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in pharmacokinetics	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine if there is a change in side effects with the addition of sitagliptin to the post-kidney transplant treatment regime.	3 months
To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c.	3 months
To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients	3 months
Determine tolerability of sitagliptin therapy in post-kidney transplant patients.	3 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: James T Lane, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 26, 2007
• First Submitted That Met QC Criteria: April 26, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: type 2 diabetes; Kidney transplant; sitagliptin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 475-06-FB