A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: Bydureon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533453

D5551L00018

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Bydureon

Experimental group

Description:

exenatide once weekly

Treatment:

Biological: Bydureon