Primary outcome· February 2013
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
| Group | Value |
|---|---|
| Part A | not posted |
| Part B | not posted |
| Part C | not posted |
| Healthy Controls | not posted |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataNew Onset Type 1 Diabetes: Role of Exenatide
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 13 participants (actual)
- Sponsor
- Albert Einstein College of Medicine · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Dec 2010
- Primary completion
- 31 Jan 2017
- Completion
- 31 Jan 2017
- First posted
- 4 Jan 2011 (estimated)
- Last update posted
- 4 Aug 2021
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102012201420162018
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- Rapid and long acting insulinDrug
- long acting insulin + rapid acting + 1.25 mcg ExenatideDrug
Arms4
Experimental
Part A
Exenatide and long acting insulin before the boost.
Active comparator
Part B
Rapid and long acting insulin before the boost
Active comparator
Part C
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
No intervention
Healthy controls
healthy controls without any medication before the boost.
Primary outcomes1
Outcomes the sponsor listed as primary.
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Time frame · February 2013
Registry description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Secondary outcomes(2)
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Time frame · February 2013
Registry description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Time frame · February 2013
Registry description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcome· February 2013
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
| Group | Value |
|---|---|
| Part A | not posted |
| Part B | not posted |
| Part C | not posted |
| Healthy Controls | not posted |
Secondary outcome· February 2013
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
| Group | Value |
|---|---|
| Part A | not posted |
| Part B | not posted |
| Part C | not posted |
| Healthy Controls | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part AExenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously. | 0 / 1 | 0 / 1 | 0 / 1 |
| Part BRapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs | 0 / 2 | 0 / 2 | 0 / 2 |
| Part Clong acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs. | 0 / 1 | 0 / 1 | 0 / 1 |
| Healthy Controlshealthy controls without any medication before the boost. | 0 / 9 | 0 / 9 | 0 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 12 Years up to 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Age between 12-18 years of age at the time of enrollment.
2. Diagnosed with antibody positive T1DM in the past 3 months.
3. Otherwise healthy except for their TIDM and treated hypothyroidism.
4. Females must have a negative pregnancy test.
5. Hemoglobin equal to or greater than 12 g/dl before each study.
6. Weight greater than 44 kg.
Exclusion Criteria:
1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
2. Any medications that may affect glucose metabolism.
3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
4. Lack of a supportive family environment as detected by the clinicians and/or social workers.
5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
6. Positive pregnancy test in females.
7. Lactating and nursing mothers.
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