Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Pramlintide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgA1c | 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 | Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post transplant diabetes mellitus