Phase 2 · Exenatide

NCT01928329 trial results

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.

Participants
79
Status
completed
Completed
2019-08
Sponsor
Yale University

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.

Primary outcome

What NCT01928329 measured first

Change From Baseline in HbA1c Levelsmmol/mol · 6 months · least squares mean
Exenatide (Bydureon)n=40Placebon=39
-0.12(0.08)0.11(0.10)
Side effects by arm

Side effects in NCT01928329

Percent of participants affected, Up to 12 months.. The most common events the registry lists.

EventExenatide (Bydureon)Placebo
Any serious event15.4%5.7%
Hypoglycemia71.8%65.7%
General disorders and administration site conditions - Other35.9%20%
Skin and subcutaneous tissue disorders - Other35.9%17.1%
Nausea33.3%14.3%
Vomiting20.5%2.9%
Gastrointestinal disorders - Other17.9%8.6%
Upper respiratory infection17.9%14.3%
Headache7.7%17.1%
Musculoskeletal and connective tissue disorder - Other15.4%11.4%
Abdominal Bloating2.6%11.4%
Nasal congestion0%11.4%
Pruritus5.1%11.4%
Injection site reaction10.3%8.6%
Diarrhea7.7%8.6%
Infections and infestations - Other2.6%8.6%
Cough0%8.6%
Rash maculo-papular0%8.6%
Dyspepsia7.7%0%
Pain in extremity7.7%0%
Bloating5.1%5.7%
Vaginal infection5.1%5.7%
Aspartate aminotransferase increased2.6%5.7%
Eye disorders - Other0%5.7%
Blood and lymphatic system disorders - Other5.1%0%
Conjunctivitis5.1%0%
Secondary outcomes

What else it measured

Change From Baseline in HbA1c Levelsmmol/mol · 12 months · least squares mean
Exenatide (Bydureon)n=40Placebon=39
0.08(0.09)0.10(0.10)
Major Hypoglycemic Event Rate On Drugevents per month · Up to 6 months · median
Exenatide (Bydureon)n=39Placebon=35
0.67(0.00 to 13.00)0.80(0.00 to 10.50)
Major Hypoglycemic Event Rate Off Drugevents per month · Up to 12 months · median
Exenatide (Bydureon)n=37Placebon=26
0.33(0.00 to 5.00)0.50(0.00 to 13.17)
The trial

How NCT01928329 was run

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)

  • Placebo: 2 mg, 1 per week via subcutaneous placebo self injection
  • Exenatide (Bydureon): 2 mg, of drug administration 1 per week via subcutaneous self injection
Who could join the trial

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.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.