Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01165944

Enrollment

Registered

2010-07-20

Start date

2009-08-31

Completion date

2011-08-31

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Post transplant diabetes mellitus

Brief summary

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

DRUGPramlintide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026