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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This study has been withdrawn prior to enrollment.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

June 9, 2010
October 2, 2012
August 2009
August 2011   (final data collection date for primary outcome measure)
HgA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Primary outcomes utilized in this study will be endpoints of HbA1C
Same as current
Complete list of historical versions of study NCT01165944 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Pramlintide
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
  • No Intervention: Standard diabetes therapy
    Standard diabetes therapy with either oral agents or insulin injections
  • Active Comparator: Oral diabetic agents and pramlintide
    Intervention: Drug: Pramlintide
  • Active Comparator: Insulin injection with pramlintide
    Intervention: Drug: Pramlintide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01165944
08-1343
No
University of Colorado, Denver
University of Colorado, Denver
Amylin Pharmaceuticals, LLC.
Principal Investigator: Boris Draznin, M.D., Ph.D. University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP