Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01165944
• Other study ID #: 08-1343
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: July 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

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