Type 1 DiabetesNCT00842075
Pramlintide in Adolescents With Type 1 Diabetes
A study testing pramlintide in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- pramlintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 13 and 17 years of age, inclusive
- Diagnosed with type 1 diabetes for > 1 year
- Hemoglobin A1c between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
Who cannot join
- Use of oral hyperglycemic agents or medications affecting blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in past 6 months
- History of hypoglycemia unawareness
- History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pramlintide in Adolescents With Type 1 Diabetes
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.
This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).
Read the detailed description
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:
- HbA1c level between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
Exclusion factors:
- Oral hyperglycemic agents or medications which might affect blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in previous 6 months
- Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.
After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.
Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.
- Conditions
- Type 1 Diabetes
- Being tested
- pramlintide
- Keywords
- type 1 diabetes, adolescents, post prandial glucose
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramlintideDrug
Also called Symlin
subcutaneous injection (15 mcg initial dose)prior to meals
| Study group | Role | What they receive |
|---|---|---|
| 1 Symlin | Experimental | Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin Receives: Drug: pramlintide |
| 2 Usual Regimen | No intervention | Usual bolus insulin dose at each meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Value After 28 Days
HbA1c values 28 days after randomization
Measured: 28
Secondary outcomes (1)
Weight Change After 28 Days Intervention Period
Mean weight change after 28 days intervention period
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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
- Peter Chase, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842075
- Sponsor's protocol ID
- 05-0724(2)
- Status last verified
- Sep 2012
- First submitted
- 20 Jan 2009
- Last updated
- 23 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kishiyama CM, Burdick PL, Cobry EC, Gage VL, Messer LH, McFann K, Chase HP. A pilot trial of pramlintide home usage in adolescents with type 1 diabetes. Pediatrics. 2009 Nov;124(5):1344-7. doi: 10.1542/peds.2008-3750. Epub 2009 Oct 26.
PubMed 19858155
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pramlintide in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00842075
- Acronym / sponsor ID
- 05-0724(2)
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, adolescents, post prandial glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 19 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.
This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).
Detailed description
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:
- HbA1c level between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
Exclusion factors:
- Oral hyperglycemic agents or medications which might affect blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in previous 6 months
- Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.
After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.
Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Symlin | Experimental | Drug: pramlintideSubcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin |
| 2 Usual Regimen | No intervention | –Usual bolus insulin dose at each meal |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 13 and 17 years of age, inclusive
- Diagnosed with type 1 diabetes for > 1 year
- Hemoglobin A1c between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
Key exclusion criteria (5 listed)
- Use of oral hyperglycemic agents or medications affecting blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in past 6 months
- History of hypoglycemia unawareness
- History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
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 |
|---|---|---|
| pramlintideAlso: Symlinsubcutaneous injection (15 mcg initial dose)prior to meals | Drug | 1 Symlin |
Primary outcome
HbA1c Value After 28 Days
Time frame: 28
HbA1c values 28 days after randomization
1 secondary outcome
Weight Change After 28 Days Intervention Period
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19858155Kishiyama CM, Burdick PL, Cobry EC, Gage VL, Messer LH, McFann K, Chase HP. A pilot trial of pramlintide home usage in adolescents with type 1 diabetes. Pediatrics. 2009 Nov;124(5):1344-7. doi: 10.1542/peds.2008-3750. Epub 2009 Oct 26.
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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.
Peter Chase, MD 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 study testing pramlintide in people with Type 1 Diabetes, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jun 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HbA1c Value After 28 Days (time frame: 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842075, which also lists 1 linked publication.
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 23 Jun 2015.