A Phase 1/2 interventional study of Pramlintide in Diabetes Mellitus, sponsored by University of Colorado, Denver. Withdrawn at 1 site in United States. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by University of Colorado, Denver · Phase 1/2, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
Browse Diabetes Mellitus studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
Standard diabetes therapy with either oral agents or insulin injections
Drug: Pramlintide
Drug: Pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
HgA1c
Primary outcomes utilized in this study will be endpoints of HbA1C
Time frame: 6 months
Continuous glucose monitoring
Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months
Time frame: 6 months
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver