Diabetes MellitusPhase 1/2NCT01165944
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
A Phase 1/2 study testing Pramlintide in people with Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pramlintide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Pramlintide
- Keywords
- Post transplant diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramlintideDrug
Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard diabetes therapy | No intervention | Standard diabetes therapy with either oral agents or insulin injections |
| Oral diabetic agents and pramlintide | Active comparator | Not described Receives: Drug: Pramlintide |
| Insulin injection with pramlintide | Active comparator | Not described Receives: Drug: Pramlintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HgA1c
Primary outcomes utilized in this study will be endpoints of HbA1C
Measured: 6 months
Secondary outcomes (1)
Continuous glucose monitoring
Secondary outcomes will include mean blood glucose levels assessed by continuous glucose monitoring (CGM) at 1, 3, and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Sponsor
- Investigators
- Boris Draznin, M.D., Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165944
- Sponsor's protocol ID
- 08-1343
- Status last verified
- Jul 2018
- First submitted
- 9 Jun 2010
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01165944
- Acronym / sponsor ID
- 08-1343
- Conditions
- Diabetes Mellitus
- Keywords
- Post transplant diabetes mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-transplant diabetes (PTMD)
- Aged 20-70
- Diagnosis of diabetes within the last 6-18 months
- Stable medications
- Stable weight for 3 months
Key exclusion criteria (7 listed)
- Pre-transplant diabetes
- Major postoperative complications following transplant
- Pregnancy
- Significant GI discomfort with nausea or vomiting
- Inability to learn continuous glucose monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PramlintidePramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks | Drug | Insulin injection with pramlintide, Oral diabetic agents and pramlintide |
Primary outcome
HgA1c
Time frame: 6 months
Primary outcomes utilized in this study will be endpoints of HbA1C
1 secondary outcome
Continuous glucose monitoring
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Draznin, M.D., Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pramlintide in people with Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HgA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.