Type 2 DiabetesPhase 4T2DMNCT00950677
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes
A Phase 4 study testing Byetta (exenatide) and Symlin (pramlintide) in people with Type 2 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 study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Byetta (exenatide) and Symlin (pramlintide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2011
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with Type 2 Diabetes,
- Between the ages of 12-21 years,
- Tanner stage 4-5 for pubertal development,
- Menstruating females must have a negative urine pregnancy test for inclusion,
- Must have T2DM for at least 6 months,
- History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,
- HbA1c < 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.
Who cannot join
- A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
- BMI> 40 kg/m2,
- Weight of < 60 kg,
- Female with menstrual irregularities,
- Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),
- Evidence or history of chemical abuse,
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- Anemia (age specific normal range for hemoglobin will be used),
- Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
- Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age),
- Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus
The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
Read the detailed description
A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.
In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.
There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.
Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.
Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Byetta (exenatide), Symlin (pramlintide)
- Keywords
- Diabetes, pramlintide, Symlin, exenatide, byetta, glucagon, gastric emptying
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Byetta (exenatide)Drug
exenatide 5 mcg subcutaneously
Symlin (pramlintide)Drug
pramlintide 60 mcg subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| exenatide | Active comparator | exenatide one dose Receives: Drug: Byetta (exenatide) |
| pramlintide | Active comparator | pramlintide one dose Receives: Drug: Symlin (pramlintide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
concentration and AUC calculations
Measured: 4 hours
Secondary outcomes (4)
glucagon
concentration and AUC calculations
Measured: 4 hrours
gastric emptying
concentration and AUC calculations
Measured: 4 hours
pramlintide concentrations
concentration and AUC calculations
Measured: 4 hours
exenatide concentrations
concentration and AUC calculations
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Luisa M. Rodriguez, Baylor College of Medicine
- Investigators
- LUISA M RODRIGUEZ, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950677
- Sponsor's protocol ID
- H-22439
- Other IDs
- K23DK075931
- Acronym
- T2DM
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2009
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00950677
- Acronym / sponsor ID
- T2DM / H-22439
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, pramlintide, Symlin, exenatide, byetta, glucagon, gastric emptying
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Aug 2009 (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 study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
Detailed description
A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.
In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.
There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.
Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.
Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exenatide | Active comparator | Drug: Byetta (exenatide)exenatide one dose |
| pramlintide | Active comparator | Drug: Symlin (pramlintide)pramlintide one dose |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children with Type 2 Diabetes,
- Between the ages of 12-21 years,
- Tanner stage 4-5 for pubertal development,
- Menstruating females must have a negative urine pregnancy test for inclusion,
- Must have T2DM for at least 6 months,
Key exclusion criteria (10 listed)
- A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
- BMI> 40 kg/m2,
- Weight of < 60 kg,
- Female with menstrual irregularities,
- Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),
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 |
|---|---|---|
| Byetta (exenatide)exenatide 5 mcg subcutaneously | Drug | exenatide |
| Symlin (pramlintide)pramlintide 60 mcg subcutaneously | Drug | pramlintide |
Primary outcome
Glucose
Time frame: 4 hours
concentration and AUC calculations
4 secondary outcomes
glucagon
Time frame: 4 hrours
gastric emptying
Time frame: 4 hours
pramlintide concentrations
Time frame: 4 hours
exenatide concentrations
Time frame: 4 hours
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 24 Apr 2017.
- Individual participant dataSharing planned: No
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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.
LUISA M RODRIGUEZ, 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 4 study testing Byetta (exenatide) and Symlin (pramlintide) in people with Type 2 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 10 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 24 Apr 2017. 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?
Glucose (time frame: 4 hours). 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 24 Apr 2017.