Type 1 DiabetesPhase 3NCT00206258
The Role of Amylin and Glucagon in T1DM
A Phase 3 study testing Pramlintide and glucagon 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 giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. 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 and glucagon
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Aug 2005
- 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
- Age >12 years < 19 years
- Have diabetes for at least 2 years and in good control (HbA1C < 8%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.
- Menstruating women must have negative pregnancy test.
- Hemoglobin equal to or > than 12 g/dL before each study.
- Weight more than 44 kg.
Who cannot join
- Age >18 or < 12 y at the time of study
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
- Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
Show all 11Show fewer
- Hgb A1c >8.0 % in a diabetic subject
- BMI > 90 % tile for age or < 10 % tile for age
- Allergy to local anesthetics (ELAMAX Cream)
- Weight less than 44 kg
- Children of staff members
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes
The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.
Read the detailed description
Objective: To develop a new treatment approach in the prevention of hypo and hyperglycemia in children with type 1diabetes.
Background/Rationale: 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 management to control blood sugar and glycosylated hemoglobin as near to normal as safely as possible is advocated. However, hypoglycemia was increased 3 fold in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar in T1DM.
Description of Project: In health individuals, "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (the hormone that raises blood sugar) play a key role in maintaining this careful balance. Recently we understand that a hormone called amylin also contributes to this careful after meal blood glucose balance. Amylin in the immediate after meal period works by reducing glucagon, which in turn reduces the liver releasing stored sugar into the blood stream.
In T1DM, there is the lack of insulin and failure of glucagon suppression leading to hyperglycemia immediately following when food is eaten. Also, glucagon is not regulated correctly after a meal. The glucagon normally produced by the body does not increase in response to hypoglycemia thus interfering with the delicate balance between glucose production and glucose used. Therefore, it is difficult to get normal blood sugar when someone has type1 diabetes.
Currently, the treatment for mild to moderate hypoglycemia causing a sudden feeling of racing heart, feeling sweaty, weak or hungry is to eat or drink carbohydrate in the awake person. Severe hypoglycemia (unconsciousness due to low blood sugar) is treated with a glucagon shot. Unfortunately, there are no treatments to prevent mild or severe hypoglycemia.
The purpose of this study is to see if giving pramlintide (manmade amylin) and insulin before a meal would lower hyperglycemia and if a glucagon shot given in the late "after meal" time would prevent hypoglycemia and allow the blood sugar levels to improve in people with T1DM. The studies outlined in this proposal might help in developing new treatment options to target "after meal" hyperglycemia high blood glucose and before meal hypoglycemia in children. This study for the first time will investigate the role of glucagon in the causation of hyperglycemia and its role in the prevention of hypoglycemia.
Relevance to Type 1 diabetes: Using naturally occurring hormones that are dysregulated or deficient in T1DM we wish to restore normal glucose concentration in T1DM. Such treatment if successful would be a major breakthrough in the prevention of hyper and hypoglycemia and in decreasing both short and long-term complications associated with T1DM.
- Conditions
- Type 1 Diabetes
- Being tested
- Pramlintide and glucagon
- 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.
Pramlintide and glucagonDrug
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 startJul 2002
- Study completionAug 2005
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 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
- 30 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
- NCT00206258
- Sponsor's protocol ID
- H-11741
- Status last verified
- Jul 2016
- First submitted
- 12 Sep 2005
- Last updated
- 14 Jul 2016
- Results posted
- No
Publications
Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. doi: 10.2337/diabetes.54.4.1100.
PubMed 15793249
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 Role of Amylin and Glucagon in the Management of Normalizing Glucose Excursions in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00206258
- Acronym / sponsor ID
- H-11741
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, hypoglycemia, hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Aug 2005
- 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 giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.
Detailed description
Objective: To develop a new treatment approach in the prevention of hypo and hyperglycemia in children with type 1diabetes.
Background/Rationale: 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 management to control blood sugar and glycosylated hemoglobin as near to normal as safely as possible is advocated. However, hypoglycemia was increased 3 fold in the DCCT study and is the major limiting factor in gaining "tight" control of blood sugar in T1DM.
Description of Project: In health individuals, "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (the hormone that raises blood sugar) play a key role in maintaining this careful balance. Recently we understand that a hormone called amylin also contributes to this careful after meal blood glucose balance. Amylin in the immediate after meal period works by reducing glucagon, which in turn reduces the liver releasing stored sugar into the blood stream.
In T1DM, there is the lack of insulin and failure of glucagon suppression leading to hyperglycemia immediately following when food is eaten. Also, glucagon is not regulated correctly after a meal. The glucagon normally produced by the body does not increase in response to hypoglycemia thus interfering with the delicate balance between glucose production and glucose used. Therefore, it is difficult to get normal blood sugar when someone has type1 diabetes.
Currently, the treatment for mild to moderate hypoglycemia causing a sudden feeling of racing heart, feeling sweaty, weak or hungry is to eat or drink carbohydrate in the awake person. Severe hypoglycemia (unconsciousness due to low blood sugar) is treated with a glucagon shot. Unfortunately, there are no treatments to prevent mild or severe hypoglycemia.
The purpose of this study is to see if giving pramlintide (manmade amylin) and insulin before a meal would lower hyperglycemia and if a glucagon shot given in the late "after meal" time would prevent hypoglycemia and allow the blood sugar levels to improve in people with T1DM. The studies outlined in this proposal might help in developing new treatment options to target "after meal" hyperglycemia high blood glucose and before meal hypoglycemia in children. This study for the first time will investigate the role of glucagon in the causation of hyperglycemia and its role in the prevention of hypoglycemia.
Relevance to Type 1 diabetes: Using naturally occurring hormones that are dysregulated or deficient in T1DM we wish to restore normal glucose concentration in T1DM. Such treatment if successful would be a major breakthrough in the prevention of hyper and hypoglycemia and in decreasing both short and long-term complications associated with T1DM.
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 (7 listed)
- Age >12 years < 19 years
- Have diabetes for at least 2 years and in good control (HbA1C < 8%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism.
- Menstruating women must have negative pregnancy test.
Key exclusion criteria (11 listed)
- Age >18 or < 12 y at the time of study
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis
- Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies)
- 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 and glucagon | 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.
- Results publication: PubMed 15793249Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. doi: 10.2337/diabetes.54.4.1100.
- Learn about the physiology of amylinLink provided by the sponsor.
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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.
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 and glucagon 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 7 inclusion and 11 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?
On the ClinicalTrials.gov record for NCT00206258, 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 14 Jul 2016.