Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

July 24, 2018 updated by: University of Colorado, Denver

Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate in response to variations in doses of steroid and other immunosuppressive agents. At the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections. The investigators hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM would help patients with post-transplant diabetes attain better control at the critical time of titration of immunosuppressive regimens. The primary objective of this proposal is to improve glycemic control of diabetes with Pramlintide in patients with post-transplant diabetes at 3 and 6 months of therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-transplant diabetes (PTMD)
  • Aged 20-70
  • Diagnosis of diabetes within the last 6-18 months
  • Stable medications
  • Stable weight for 3 months
  • Serum creatinine < 1.5 mg/dL

Exclusion Criteria:

  • Pre-transplant diabetes
  • Major postoperative complications following transplant
  • Pregnancy
  • Significant GI discomfort with nausea or vomiting
  • Inability to learn continuous glucose monitoring
  • Development of diabetes more than 4 years after transplant
  • omen of child-bearing potential who use birth control pills and have fasting triglycerides of > 400 mg/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard diabetes therapy
Standard diabetes therapy with either oral agents or insulin injections
Active Comparator: Oral diabetic agents and pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
Active Comparator: Insulin injection with pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HgA1c
Time Frame: 6 months
Primary outcomes utilized in this study will be endpoints of HbA1C
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous glucose monitoring
Time Frame: 6 months
Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Boris Draznin, M.D., Ph.D., University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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