Status:
WITHDRAWN
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01165944
Start Date
August 1 2009
End Date
August 1 2011
Last Update
July 26 2018
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045