Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

NCT ID: NCT01165944

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-08-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard diabetes therapy

Standard diabetes therapy with either oral agents or insulin injections

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral diabetic agents and pramlintide

Group Type: ACTIVE_COMPARATOR

Pramlintide

Intervention Type: DRUG

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

Insulin injection with pramlintide

Group Type: ACTIVE_COMPARATOR

Pramlintide

Intervention Type: DRUG

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

Interventions

Pramlintide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Draznin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

08-1343

Identifier Type: -

Identifier Source: org_study_id