Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

NCT01165944 | Withdrawn Phase 1

• 1 other identifier: 08-1343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Post transplant diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• HgA1c

  Primary outcomes utilized in this study will be endpoints of HbA1C

  6 months

Secondary Outcomes (1)

• Continuous glucose monitoring

  6 months

Study Arms (3)

Standard diabetes therapy

NO INTERVENTION

Standard diabetes therapy with either oral agents or insulin injections

Oral diabetic agents and pramlintide

ACTIVE COMPARATOR

Drug: Pramlintide

Insulin injection with pramlintide

ACTIVE COMPARATOR

Drug: Pramlintide

Interventions

Pramlintide DRUG

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

Insulin injection with pramlintide; Oral diabetic agents and pramlintide

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Boris Draznin, M.D., Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: July 20, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (1)