Primary outcomeNumber· baseline and 12/24 weeks
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
| Group | Value (percentage of participants) |
|---|---|
| 12/24 Weeks Treatment | 52.9 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Short name Bydureon
NCTNCT02533453 (opens ClinicalTrials.gov in a new tab)Other idD5551L00018
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 110 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
South Korea
- Start
- 28 Jan 2016
- Primary completion
- 7 Dec 2016
- Completion
- 7 Dec 2016
- First posted
- 26 Aug 2015 (estimated)
- Last update posted
- 31 May 2019
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20162017
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BydureonBiological
Arms1
Experimental
Bydureon
exenatide once weekly
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
Time frame · baseline and 12/24 weeks
Registry description
was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance.
Secondary outcomes(5)
Change in HbA1c
Time frame · baseline and 12/24 weeks
Registry description
Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Change in Fasting Plasma Gloucose
Time frame · baseline and 12/24 weeks
Registry description
Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Change in Body Weight
Time frame · baseline and 12/24 weeks
Registry description
Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Change in Vital Sign
Time frame · baseline and 12/24 weeks
Registry description
Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Evaluation of "Subjective Improvement of Main Indication"
Time frame · baseline and 12/24 weeks
Registry description
"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
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(5)
Secondary outcomeMean· baseline and 12/24 weeks
Change in HbA1c
| Group | Value (percentage of Hba1c) | Spread |
|---|---|---|
| 12/24 Weeks Treatment | -1.21 | 1.10 |
Secondary outcomeMean· baseline and 12/24 weeks
Change in Fasting Plasma Gloucose
| Group | Value (mg/dL) | Spread |
|---|---|---|
| 12/24 Weeks Treatment | -34.2 | 48.3 |
Secondary outcomeMean· baseline and 12/24 weeks
Change in Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| 12/24 Weeks Treatment | -0.95 | 2.86 |
Secondary outcomeMean· baseline and 12/24 weeks
Change in Vital Sign
| Group | Value (mmHg) | Spread |
|---|---|---|
| 12/24 Weeks Treatment | -3.35 | 11.95 |
Secondary outcomeNumber· baseline and 12/24 weeks
Evaluation of "Subjective Improvement of Main Indication"
| Group | Value (participants) |
|---|---|
| 12/24 Weeks Treatment | 84 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 12/24 Weeks TreatmentExenatide 2mg / 12/24 weeks treatment | – | 4 / 104 | 55 / 104 |
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 19 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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:
1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
3. DPP-4 inhibitors within 30 days of screening;
4. Regular use (\> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
5. 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;
6. 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)
PepBank is a research reference. Talk to a doctor before you use any peptide.