Type 1 DiabetesPhase 2NCT00456300
Role of Exenatide in Type 1 Diabetes
A Phase 2 study testing Exenatide and Insulin in people with Type 1 Diabetes, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exenatide and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 2
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be patients of the Texas Children's Hospital Diabetes Care Center.
- All of the following criteria must be met:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
- Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
Show all 9Show fewer
- Hemoglobin equal to or greater than 12 g/dL before each study.
- Weight greater than 44 kg.
- Tanner stage greater than 3
Who cannot join
- 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.
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- Positive pregnancy test in menstruating young women.
- BMI greater than 90th percentile for age or less than 10th percentile for age.
- Lactating and nursing mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: The Role of Exenatide in Type 1 Diabetes Mellitus
The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.
Read the detailed description
A large study in people with type 1 diabetes (T1DM) 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. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less.
Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults.
Study Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart.
Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of [13C] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study.
On the days subjects received the study drug of 1.25 µ,g (~0.02 µ,g/kg) or 2.5 µ,g (~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%.
Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy.
- Conditions
- Type 1 Diabetes
- Being tested
- Exenatide, Insulin
- Keywords
- 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.
ExenatideDrug
Also called Byetta
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
InsulinDrug
Each subject received a baseline study with insulin alone
| Study group | Role | What they receive |
|---|---|---|
| Exenatide 1.25 mcg + Insulin | Experimental | In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection Receives: Drug: Exenatide; Drug: Insulin |
| Exenatide 2.5 mcg + Insulin | Experimental | In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection Receives: Drug: Exenatide; Drug: Insulin |
| Insulin | Active comparator | Each subject received a baseline study with insulin alone Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone
Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection
Measured: 0-120 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 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 Montefiore Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Rubina Heptulla, Montefiore Medical Center
- Investigators
- Rubina Heptulla, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456300
- Sponsor's protocol ID
- H-16488
- Status last verified
- Feb 2019
- First submitted
- 3 Apr 2007
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raman VS, Mason KJ, Rodriguez LM, Hassan K, Yu X, Bomgaars L, Heptulla RA. The role of adjunctive exenatide therapy in pediatric type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1294-6. doi: 10.2337/dc09-1959. Epub 2010 Mar 23.
PubMed 20332358
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exenatide in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00456300
- Acronym / sponsor ID
- H-16488
- Conditions
- Type 1 Diabetes
- Keywords
- Hypoglycemia, Hyperglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2007 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Posted 26 Feb 2019
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 exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.
Detailed description
A large study in people with type 1 diabetes (T1DM) 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. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less.
Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults.
Study Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart.
Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of [13C] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study.
On the days subjects received the study drug of 1.25 µ,g (~0.02 µ,g/kg) or 2.5 µ,g (~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%.
Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide 1.25 mcg + Insulin | Experimental | Drug: Exenatide, Drug: InsulinIn each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection |
| Exenatide 2.5 mcg + Insulin | Experimental | Drug: Exenatide, Drug: InsulinIn each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection |
| Insulin | Active comparator | Drug: InsulinEach subject received a baseline study with insulin alone |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Subjects must be patients of the Texas Children's Hospital Diabetes Care Center.
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
- Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
Key exclusion criteria (5 listed)
- 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.
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- Positive pregnancy test in menstruating young women.
- BMI greater than 90th percentile for age or less than 10th percentile for age.
- Lactating and nursing mothers.
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 |
|---|---|---|
| ExenatideAlso: ByettaIn each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide. | Drug | Exenatide 1.25 mcg + Insulin, Exenatide 2.5 mcg + Insulin |
| InsulinEach subject received a baseline study with insulin alone | Drug | Exenatide 1.25 mcg + Insulin, Exenatide 2.5 mcg + Insulin, Insulin |
Primary outcome
Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone
Time frame: 0-120 minutes post-dose
Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20332358Raman VS, Mason KJ, Rodriguez LM, Hassan K, Yu X, Bomgaars L, Heptulla RA. The role of adjunctive exenatide therapy in pediatric type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1294-6. doi: 10.2337/dc09-1959. Epub 2010 Mar 23.
- 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.
Rubina Heptulla, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide and Insulin in people with Type 1 Diabetes, run by Montefiore Medical Center 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 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 26 Feb 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). 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?
Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone (time frame: 0-120 minutes post-dose). 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 NCT00456300, 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 26 Feb 2019.