Type 1 DiabetesPhase 4NCT01269034
New Onset Type 1 Diabetes: Role of Exenatide
A Phase 4 study testing Exenatide, Rapid and long acting insulin and long acting insulin + rapid acting + 1.25 mcg Exenatide in people with Type 1 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exenatide, Rapid and long acting insulin and long acting insulin + rapid acting + 1.25 mcg Exenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 31 Jan 2017
- Phase
- Phase 4
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 12-18 years of age at the time of enrollment.
- Diagnosed with antibody positive T1DM in the past 3 months.
- Otherwise healthy except for their TIDM and treated hypothyroidism.
- Females must have a negative pregnancy test.
- Hemoglobin equal to or greater than 12 g/dl before each study.
- Weight greater than 44 kg.
Who cannot join
- Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
- Any medications that may affect glucose metabolism.
- Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
- Positive pregnancy test in females.
- Lactating and nursing mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein CRC- West Campus
The Bronx, New York, 10467
About this study
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.
Read the detailed description
The specific aims of this study are to determine the following:
- The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia.
- The role of exenatide on postprandial glucagon and gastric emptying.
- The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying.
- Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.
Study Design:
A randomized, non-blinded trial with a crossover design will be used. Following informed consent and with appropriate subject assent, all subjects will have a screening visit. Following the screening visit, subjects with T1DM will undergo 3 studies: Part A (exenatide and long acting insulin), Part B (rapid and long acting insulin) and Part C (long acting insulin only). The subjects will be admitted to the CRC on three separate occasions, at least 3-4 weeks apart. The three studies will be performed in a random order and the randomization will be done using a computerized system. The healthy controls will undergo a single study visit. Except for the absence of diabetes, the healthy controls will be identical to the study subjects. Subjects with new onset diabetes will be compared to healthy controls.
During the study, if blood glucose values in a subject are less than 55 mg/dl, IV glucose of 5-15 grams will be administered to achieve euglycemia (90-130 mg/dl). 1-2 doses of IV glucose should correct hypoglycemia. If more than 3 doses are required to achieve euglycemia, the study will be terminated, the subject will be offered a meal tray and blood sugar rechecked to ensure euglycemia. If blood sugar at any time is more than 350 with moderate ketones, the study will be terminated.
At around 1 PM (270 min), lunch will be provided (consistent carbohydrate meal) and insulin will be given as per the subject's prescribed regimen. The subject will be discharged home with a designated driver due to the risk of hypoglycemia.
A subject will be withdrawn from participating in the study if he/she meets any of the following conditions: 1)develops a chronic disease 2)develops anemia 3)becomes pregnant 4)develops a weight loss of greater than 10 pounds for unspecified reasons 5)loss of contact- if the investigators are unable to reach a study subject (within 2 months of screening or completion of the first study) by phone or mail to schedule the next appointment. All study subjects (that are withdrawn from the study) will receive a phone call and a letter notifying them that they have been withdrawn.
- Conditions
- Type 1 Diabetes
- Being tested
- Exenatide, Rapid and long acting insulin, long acting insulin + rapid acting + 1.25 mcg Exenatide
- Keywords
- Type 1 diabetes Milletus, diabetes, healthy controls, exenatide, byetta
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
1.25 mcg before the boost sub-cutaneously.
Rapid and long acting insulinDrug
Also called Novolog/ Humalog, Lantus/ Levemir
Depends on their Carbohydrate ratio and body needs
long acting insulin + rapid acting + 1.25 mcg ExenatideDrug
Also called Lantus, Levemir
Depends on their body needs.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Exenatide and long acting insulin before the boost. Receives: Drug: Exenatide |
| Part B | Active comparator | Rapid and long acting insulin before the boost Receives: Drug: Rapid and long acting insulin |
| Part C | Active comparator | long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost Receives: Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide |
| Healthy controls | No intervention | healthy controls without any medication before the boost. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Measured: February 2013
Secondary outcomes (2)
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Measured: February 2013
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Measured: February 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
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.
- Other trials for Type 1 DiabetesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranjitha Katikaneni, MB; BS, Study director, Montefiore Children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269034
- Sponsor's protocol ID
- 2010-435
- Other IDs
- 3R01DK077166-05S1
- Status last verified
- Jul 2021
- First submitted
- 29 Dec 2010
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Onset Type 1 Diabetes: Role of Exenatide
- ClinicalTrials.gov ID
- NCT01269034
- Acronym / sponsor ID
- 2010-435
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes Milletus, diabetes, healthy controls, exenatide, byetta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2010
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Posted 4 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.
Detailed description
The specific aims of this study are to determine the following:
- The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia.
- The role of exenatide on postprandial glucagon and gastric emptying.
- The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying.
- Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.
Study Design:
A randomized, non-blinded trial with a crossover design will be used. Following informed consent and with appropriate subject assent, all subjects will have a screening visit. Following the screening visit, subjects with T1DM will undergo 3 studies: Part A (exenatide and long acting insulin), Part B (rapid and long acting insulin) and Part C (long acting insulin only). The subjects will be admitted to the CRC on three separate occasions, at least 3-4 weeks apart. The three studies will be performed in a random order and the randomization will be done using a computerized system. The healthy controls will undergo a single study visit. Except for the absence of diabetes, the healthy controls will be identical to the study subjects. Subjects with new onset diabetes will be compared to healthy controls.
During the study, if blood glucose values in a subject are less than 55 mg/dl, IV glucose of 5-15 grams will be administered to achieve euglycemia (90-130 mg/dl). 1-2 doses of IV glucose should correct hypoglycemia. If more than 3 doses are required to achieve euglycemia, the study will be terminated, the subject will be offered a meal tray and blood sugar rechecked to ensure euglycemia. If blood sugar at any time is more than 350 with moderate ketones, the study will be terminated.
At around 1 PM (270 min), lunch will be provided (consistent carbohydrate meal) and insulin will be given as per the subject's prescribed regimen. The subject will be discharged home with a designated driver due to the risk of hypoglycemia.
A subject will be withdrawn from participating in the study if he/she meets any of the following conditions: 1)develops a chronic disease 2)develops anemia 3)becomes pregnant 4)develops a weight loss of greater than 10 pounds for unspecified reasons 5)loss of contact- if the investigators are unable to reach a study subject (within 2 months of screening or completion of the first study) by phone or mail to schedule the next appointment. All study subjects (that are withdrawn from the study) will receive a phone call and a letter notifying them that they have been withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: ExenatideExenatide and long acting insulin before the boost. |
| Part B | Active comparator | Drug: Rapid and long acting insulinRapid and long acting insulin before the boost |
| Part C | Active comparator | Drug: long acting insulin + rapid acting + 1.25 mcg Exenatidelong acting insulin+ rapid acting+1.25 mcg Exenatide before the boost |
| Healthy controls | No intervention | –healthy controls without any medication before the boost. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 12-18 years of age at the time of enrollment.
- Diagnosed with antibody positive T1DM in the past 3 months.
- Otherwise healthy except for their TIDM and treated hypothyroidism.
- Females must have a negative pregnancy test.
- Hemoglobin equal to or greater than 12 g/dl before each study.
Key exclusion criteria (7 listed)
- Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
- Any medications that may affect glucose metabolism.
- Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
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: Byetta1.25 mcg before the boost sub-cutaneously. | Drug | Part A |
| Rapid and long acting insulinAlso: Novolog/ Humalog, Lantus/ LevemirDepends on their Carbohydrate ratio and body needs | Drug | Part B |
| long acting insulin + rapid acting + 1.25 mcg ExenatideAlso: Lantus, LevemirDepends on their body needs. | Drug | Part C |
Primary outcome
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Time frame: February 2013
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
2 secondary outcomes
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Time frame: February 2013
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Time frame: February 2013
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ranjitha Katikaneni, MB; BS study director
Montefiore Children's hospital
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 Exenatide, Rapid and long acting insulin and long acting insulin + rapid acting + 1.25 mcg Exenatide in people with Type 1 Diabetes, run by Albert Einstein 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 6 inclusion and 7 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 4 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2021). 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?
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia. (time frame: February 2013). 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 4 Aug 2021.