Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment bydureon
Phase phase 4
Sponsor AstraZeneca
Start date January 2016
End date January 2017
Trial size 115 participants
Trial identifier NCT02533453, D5551L00018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
exenatide once weekly
bydureon exenatide
exenatide once weekly

Primary Outcomes

Measure
•Percentage of patients with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly
time frame: Assessed up to 12/24 weeks
• Nature, incidence and severity of Adverse Events (AE) in patients who are treated with 2 mg exenatide once weekly.
time frame: Assessed up to 12/24 months

Secondary Outcomes

Measure
• Change in HbA1c at 4, 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
time frame: Assessed up to 12/24 weeks
• Change in fasting plasma glucose at 4, 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
time frame: Assessed up to 12/24 months
• Change in blood pressure at 4, 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
time frame: Assessed up to 12/24 months
• Change in body weight at 4, 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
time frame: Assessed up to 12/24 months
• "Subjective improvement of main indication" will be assessed as either "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
time frame: Assessed up to 12/24 months

Eligibility Criteria

Male or female participants from 19 years up to 75 years old.

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)

Additional Information

Official title A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.