Type 1 DiabetesPhase 3NCT00206297
The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
A Phase 3 study testing Pramlintide in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pramlintide
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Feb 2006
- Phase
- Phase 3
- 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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with diabetes for at least 2 years and in good control (HbA1C less than 8.5%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
- Hemoglobin equal to or > 12 g/dL before each study.
- Weight more than 44 kg. -
Who cannot join
- Age greater than 22 years or less than 12 years at the time of study
- Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
- Anemia (hemoglobin less than 12mg/dl)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
Show all 9Show fewer
- Hgb A1C greater than or equal to 8.5 % in a diabetic subject
- BMI > 90 % tile for age or < 10 % tile for age
- Weight less than 44 kg. -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours
Read the detailed description
The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term complications. As a result of the study, intensive insulin management is aimed to control blood sugar and glycosylated hemoglobin (3 month blood glucose average test) as near to normal as safely possible. However, hypoglycemia (low blood sugar) was increased three fold in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar in T1DM.
In healthy individuals, an "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in maintaining this careful balance. In T1DM, there is a lack of insulin and failure of glucagon suppression (keeping glucagon from being made too much). This leads to hyperglycemia (high blood sugar) right after you eat food. Also, glucagon is not controlled correctly after a meal. The glucagon, normally produced by the body, does not increase when a person with T1DM has a low blood sugar. This interferes with the balance between how much glucose is made and how much glucose is used. Therefore, glucagon fails to protect against low blood sugar in people with T1DM. This makes it very difficult to have normal blood sugars when someone has T1DM. This imbalance may be due to another hormone called amylin. This hormone may be too low in people with T1DM.
Amylin is produced in the pancreas (the part of the body that makes insulin) by the same cells that produce insulin and is also lacking in persons with T1DM. Amylin works by lowering glucagon after a meal. This keeps the liver from letting out stored sugar into the blood stream right after we eat. Pramlintide is man-made amylin and is given as a subcutaneous shot (under the skin) similar to insulin. At present, pramlintide has not received FDA approval.
Studies performed in adults have shown that adding amylin in T1DM, using pramlintide, lowers the high levels of glucagon made after a meal. This results in improved "after meal" high blood sugars and overall blood sugar control. Currently, pramlintide in adults is given as a separate injection from insulin, before meals, three times a day. When given as a bolus shot (one dose shot given all at once) to children and young adults, it seems to cause immediate low blood sugars after a meal. The low blood sugars may be caused by the "slowing down" of food digestion by pramlintide. Another possible cause of the low blood sugars may be the way pramlintide is being given (bolus shot versus a dual wave infusion).
- Conditions
- Type 1 Diabetes
- Being tested
- Pramlintide
- Keywords
- Type 1 diabetes, hypoglycemia, hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramlintideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for glucose
Secondary outcomes (1)
glucagon and gastric emptying
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sponsored Programs, Baylor College of Medicine
- Investigators
- Rubina Heptulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206297
- Sponsor's protocol ID
- H-14358
- Status last verified
- Jul 2016
- First submitted
- 12 Sep 2005
- Last updated
- 14 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolonged Pramlintide Infusion in Pediatric Diabetes
- ClinicalTrials.gov ID
- NCT00206297
- Acronym / sponsor ID
- H-14358
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, hypoglycemia, hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Feb 2006
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to see if reducing the dose of insulin before a meal and giving both pramlintide and insulin as dual wave infusions will lower the chance of low blood sugars after a meal. In addition, the study will look at giving pramlintide as a basal infusion (a very low steady dose) for several hours
Detailed description
The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term complications. As a result of the study, intensive insulin management is aimed to control blood sugar and glycosylated hemoglobin (3 month blood glucose average test) as near to normal as safely possible. However, hypoglycemia (low blood sugar) was increased three fold in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar in T1DM.
In healthy individuals, an "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in maintaining this careful balance. In T1DM, there is a lack of insulin and failure of glucagon suppression (keeping glucagon from being made too much). This leads to hyperglycemia (high blood sugar) right after you eat food. Also, glucagon is not controlled correctly after a meal. The glucagon, normally produced by the body, does not increase when a person with T1DM has a low blood sugar. This interferes with the balance between how much glucose is made and how much glucose is used. Therefore, glucagon fails to protect against low blood sugar in people with T1DM. This makes it very difficult to have normal blood sugars when someone has T1DM. This imbalance may be due to another hormone called amylin. This hormone may be too low in people with T1DM.
Amylin is produced in the pancreas (the part of the body that makes insulin) by the same cells that produce insulin and is also lacking in persons with T1DM. Amylin works by lowering glucagon after a meal. This keeps the liver from letting out stored sugar into the blood stream right after we eat. Pramlintide is man-made amylin and is given as a subcutaneous shot (under the skin) similar to insulin. At present, pramlintide has not received FDA approval.
Studies performed in adults have shown that adding amylin in T1DM, using pramlintide, lowers the high levels of glucagon made after a meal. This results in improved "after meal" high blood sugars and overall blood sugar control. Currently, pramlintide in adults is given as a separate injection from insulin, before meals, three times a day. When given as a bolus shot (one dose shot given all at once) to children and young adults, it seems to cause immediate low blood sugars after a meal. The low blood sugars may be caused by the "slowing down" of food digestion by pramlintide. Another possible cause of the low blood sugars may be the way pramlintide is being given (bolus shot versus a dual wave infusion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Twenty (20) children with T1DM will be recruited for these studies. These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with diabetes for at least 2 years and in good control (HbA1C less than 8.5%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
Key exclusion criteria (9 listed)
- Age greater than 22 years or less than 12 years at the time of study
- Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
- Anemia (hemoglobin less than 12mg/dl)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
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 |
|---|---|---|
| Pramlintide | Drug | – |
Primary outcome
Area under the curve for glucose
1 secondary outcome
glucagon and gastric emptying
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 14 Jul 2016.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Rubina Heptulla, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pramlintide in people with Type 1 Diabetes, run by Baylor College of Medicine 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 8 inclusion and 9 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 14 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Area under the curve for glucose. 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 14 Jul 2016.