IDDMPhase 4NCT00502138
A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes
A Phase 4 study testing Continuous Pramlintide infusion in people with IDDM, run by University Diabetes & Endocrine Consultants at 1 site in United States.
Trial summary
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IDDM
- What is being tested?
- Continuous Pramlintide infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2008
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes of at least one year duration;
- Treated with CSII therapy for at least 6 months;
- Age 18 to 70 years, inclusive;
- A1C >7.0 and ≤10% as screening;
- BMI ≤35 kg/m2;
- Stable insulin dose (±10%) for at least 3 months prior to screening;
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- If female, has a negative urine pregnancy test at screening;
- If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study;
- Able to understand and sign the required study documents and comply with the protocol requirements
Who cannot join
- Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;
- Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being;
- If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;
- Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;
- Has a history of hypoglycemia unawareness;
- Has a confirmed diagnosis of gastroparesis;
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- Requires the use of drugs that stimulate gastrointestinal motility;
- Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids);
- Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit;
- Has been treated with pramlintide within 3 months of screening visit;
- Has received an investigational drug within 3 month of screening visit;
- Is currently participating in a clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37403
About this study
Official title: A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.
Read the detailed description
DESCRIPTION OF STUDY:
To participate in the study, you must have Type I diabetes mellitus and be taking insulin using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not be permitted to participate in the study if you have taken pramlintide (Symlin) during the previous three months. The study will consist of seven visits to the Study Center over a four-month period. Subjects will undergo meal tolerance testing at beginning and end of study period. Continuous blood glucose monitoring will be performed on three occasions during the study.
Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be begun thereafter per standard manufacturer protocol. Subjects will be monitored for three months on basal-bolus pramlintide therapy.
- Conditions
- IDDM
- Being tested
- Continuous Pramlintide infusion
- Keywords
- diabetes, insulin, pramlintide, IDDM
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Pramlintide infusionDrug
Also called pramlintide
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion Receives: Drug: Continuous Pramlintide infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial pramlintide pharmacokinetics
Measured: Four months
Secondary outcomes (2)
Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction
Measured: four months
Hemoglobin A1c
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IDDMStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Diabetes & Endocrine Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Principal investigator, David M. Huffman MD, University Diabetes & Endocrine Consultants
- Investigators
- David M Huffman, MD, Principal investigator, University Diabetes & Endocrine Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502138
- Sponsor's protocol ID
- Pramlintide Infusion in IDDM
- Status last verified
- Jan 2013
- First submitted
- 16 Jul 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huffman DM, McLean GW, Seagrove MA. Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study. Endocr Pract. 2009 Nov-Dec;15(7):689-95. doi: 10.4158/EP09044.ORR1.
PubMed 19546056
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00502138
- Acronym / sponsor ID
- Pramlintide Infusion in IDDM
- Conditions
- IDDM
- Keywords
- diabetes, insulin, pramlintide, IDDM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Diabetes & Endocrine ConsultantsUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Jul 2007 (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.
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.
Detailed description
DESCRIPTION OF STUDY:
To participate in the study, you must have Type I diabetes mellitus and be taking insulin using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not be permitted to participate in the study if you have taken pramlintide (Symlin) during the previous three months. The study will consist of seven visits to the Study Center over a four-month period. Subjects will undergo meal tolerance testing at beginning and end of study period. Continuous blood glucose monitoring will be performed on three occasions during the study.
Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be begun thereafter per standard manufacturer protocol. Subjects will be monitored for three months on basal-bolus pramlintide therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Continuous Pramlintide infusionInterventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 1 diabetes of at least one year duration;
- Treated with CSII therapy for at least 6 months;
- Age 18 to 70 years, inclusive;
- A1C >7.0 and ≤10% as screening;
- BMI ≤35 kg/m2;
Key exclusion criteria (12 listed)
- Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;
- Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being;
- If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;
- Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;
- Has a history of hypoglycemia unawareness;
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 |
|---|---|---|
| Continuous Pramlintide infusionAlso: pramlintidepramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses | Drug | A |
Primary outcome
Fasting and postprandial pramlintide pharmacokinetics
Time frame: Four months
2 secondary outcomes
Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction
Time frame: four months
Hemoglobin A1c
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 19546056Huffman DM, McLean GW, Seagrove MA. Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study. Endocr Pract. 2009 Nov-Dec;15(7):689-95. doi: 10.4158/EP09044.ORR1.
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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.
David M Huffman, MD principal investigator
University Diabetes & Endocrine Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Pramlintide infusion in people with IDDM, run by University Diabetes & Endocrine Consultants 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 9 inclusion and 12 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 16 Jan 2013. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fasting and postprandial pramlintide pharmacokinetics (time frame: Four months). 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 NCT00502138, 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 16 Jan 2013.