- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165944
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
July 24, 2018 updated by: University of Colorado, Denver
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard diabetes therapy
Standard diabetes therapy with either oral agents or insulin injections
|
|
Active Comparator: Oral diabetic agents and pramlintide
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Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
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Active Comparator: Insulin injection with pramlintide
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Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HgA1c
Time Frame: 6 months
|
Primary outcomes utilized in this study will be endpoints of HbA1C
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous glucose monitoring
Time Frame: 6 months
|
Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Boris Draznin, M.D., Ph.D., University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
August 1, 2011
Study Completion (Anticipated)
August 1, 2011
Study Registration Dates
First Submitted
June 9, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (Estimate)
July 20, 2010
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 24, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-1343
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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