Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT01165944·Phase 1 / Phase 2·INTERVENTIONAL

Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

PramlintideOtherWithdrawn

Status

Withdrawn

Phase

Phase 1 / Phase 2

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Pramlintide

Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks

Timeline

From registration to results.

  1. First posted

    Jul 20, 2010

  2. Study start

    Aug 2009

  3. Primary completion

    Aug 2011

  4. Study completion

    Aug 2011

  5. Results posted

    Not reported

  6. Registry updated

    Jul 26, 2018

Outcomes

What the study measures.

Primary outcomes

HgA1c

Time frame · 6 months

Primary outcomes utilized in this study will be endpoints of HbA1C

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Colorado Denver

Aurora, Colorado, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsPramlintide trial dashboard →