Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01165944

Run by

University of Colorado, Denver

People needed

0

Starts

2009-08-01

Expected to finish

2011-08-01

Last updated by the study team

2018-07-26

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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