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Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01165944
First received: June 9, 2010
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
 Drug: Pramlintide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • HgA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary outcomes utilized in this study will be endpoints of HbA1C


Secondary Outcome Measures:
  • Continuous glucose monitoring [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months


Enrollment: 0
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard diabetes therapy
Standard diabetes therapy with either oral agents or insulin injections
Active Comparator: Oral diabetic agents and pramlintide Drug: Pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
Active Comparator: Insulin injection with pramlintide Drug: Pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165944

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Boris Draznin, M.D., Ph.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01165944     History of Changes
Other Study ID Numbers: 08-1343
Study First Received: June 9, 2010
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Post transplant diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013