Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Phase 1

Withdrawn

• Conditions: Diabetes Mellitus
• Interventions: Drug: Pramlintide

• Registration Number: NCT01165944
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral diabetic agents and pramlintide	Pramlintide	-
Insulin injection with pramlintide	Pramlintide	-

Primary Outcome Measures

Name	Time	Method
HgA1c	6 months	Primary outcomes utilized in this study will be endpoints of HbA1C

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States