What NCT01928329 measured first
| Exenatide (Bydureon)n=40 | Placebon=39 |
|---|---|
| -0.12(0.08) | 0.11(0.10) |
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Change From Baseline in HbA1c Levels (mmol/mol), 6 months. Exenatide (Bydureon): -0.12; Placebo: 0.11.
As posted on ClinicalTrials.gov (NCT01928329), updated at source Mar 19, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Exenatide (Bydureon)n=40 | Placebon=39 |
|---|---|
| -0.12(0.08) | 0.11(0.10) |
Percent of participants affected, Up to 12 months.. The most common events the registry lists.
| Event | Exenatide (Bydureon) | Placebo |
|---|---|---|
| Any serious event | 15.4% | 5.7% |
| Hypoglycemia | 71.8% | 65.7% |
| General disorders and administration site conditions - Other | 35.9% | 20% |
| Skin and subcutaneous tissue disorders - Other | 35.9% | 17.1% |
| Nausea | 33.3% | 14.3% |
| Vomiting | 20.5% | 2.9% |
| Gastrointestinal disorders - Other | 17.9% | 8.6% |
| Upper respiratory infection | 17.9% | 14.3% |
| Headache | 7.7% | 17.1% |
| Musculoskeletal and connective tissue disorder - Other | 15.4% | 11.4% |
| Abdominal Bloating | 2.6% | 11.4% |
| Nasal congestion | 0% | 11.4% |
| Pruritus | 5.1% | 11.4% |
| Injection site reaction | 10.3% | 8.6% |
| Diarrhea | 7.7% | 8.6% |
| Infections and infestations - Other | 2.6% | 8.6% |
| Cough | 0% | 8.6% |
| Rash maculo-papular | 0% | 8.6% |
| Dyspepsia | 7.7% | 0% |
| Pain in extremity | 7.7% | 0% |
| Bloating | 5.1% | 5.7% |
| Vaginal infection | 5.1% | 5.7% |
| Aspartate aminotransferase increased | 2.6% | 5.7% |
| Eye disorders - Other | 0% | 5.7% |
| Blood and lymphatic system disorders - Other | 5.1% | 0% |
| Conjunctivitis | 5.1% | 0% |
| Exenatide (Bydureon)n=40 | Placebon=39 |
|---|---|
| 0.08(0.09) | 0.10(0.10) |
| Exenatide (Bydureon)n=39 | Placebon=35 |
|---|---|
| 0.67(0.00 to 13.00) | 0.80(0.00 to 10.50) |
| Exenatide (Bydureon)n=37 | Placebon=26 |
|---|---|
| 0.33(0.00 to 5.00) | 0.50(0.00 to 13.17) |
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)
Inclusion Criteria * Male or female aged 18-65 years who meets the American Diabetes Association standard T1DM criteria. * Diagnosis of T1DM at least 2 years from Visit 0 * Insulin Requirement of ≤ 0.90 units/kg * Absence of ketoacidosis in the past 6 months * HbA1c of ≥ 6.5% and ≤ 9.5% * Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period * Signed informed consent Exclusion Criteria: * Inability or unwillingness to give informed consent * Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status. * Known hypersensitivity to Exenatide, Liraglutide or any product component. * Participation in an investigational treatment trial within the last 6 weeks before enrollment. * 1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months. * Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis. * Known severe renal impairment, end-stage renal disease or renal transplantation. * Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma. * Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment. * Clinically active serious infection. * Positive pregnancy test in menstruating women or lactating females. * Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.