Phase 4
Completed N=110
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Source: ClinicalTrials.gov NCT02533453 ↗Enrolled (actual)
110
Serious AEs
3.9%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) — 52.9; 3.8 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) |
52.9; 3.8 | — |
| SECONDARY Change in HbA1c |
-1.21 | — |
| SECONDARY Change in Fasting Plasma Gloucose |
-34.2 | — |
| SECONDARY Change in Body Weight |
-0.95 | — |
| SECONDARY Change in Vital Sign |
-3.35; -0.15 | — |
| SECONDARY Evaluation of "Subjective Improvement of Main Indication" |
84; 11; 6; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 19-75 years of age
- diagnosed with type 2 diabetes mellitus
- Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;
- Metformin
- Sulphonylurea
- Thiazolidinedione
- Metformin and sulphonylurea
- Metformin and thiazolidinedione
Exclusion Criteria
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- DPP-4 inhibitors within 30 days of screening;
- Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
- Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
- GLP-1 receptor agonist except exenatide within 3 months of screening;
- diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
- type 2 diabetes by beta-cell dysfunction requiring insulin treatment
- Has ever used exenatide
- Pregnant or breast feeding patients
- Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal
- End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
Data sourced from ClinicalTrials.gov (NCT02533453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.