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Trial · Interventional

WithdrawnPhase 1/2Registry data

Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

NCTNCT01165944 (opens ClinicalTrials.gov in a new tab)Other id08-1343
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Overview

Status
Withdrawn
Phase
Phase 1/2
Enrollment
0 participants (actual)
Sponsor
University of Colorado, Denver · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2009
Primary completion
Aug 2011 (estimated)
Completion
Aug 2011 (estimated)
First posted
20 Jul 2010 (estimated)
Last update posted
26 Jul 2018
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 1/2

    Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

    NCT01165944

    Aug 2009 to est. Aug 2011

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PramlintideDrug

Arms3

  • No intervention

    Standard diabetes therapy

    Standard diabetes therapy with either oral agents or insulin injections

  • Active comparator

    Oral diabetic agents and pramlintide

  • Active comparator

    Insulin injection with pramlintide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HgA1c

    Time frame · 6 months

    Registry description

    Primary outcomes utilized in this study will be endpoints of HbA1C

Secondary outcomes(1)

  1. Continuous glucose monitoring

    Time frame · 6 months

    Registry description

    Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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