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Twin-exenatide Study

Phase 4
Conditions
Adult patients with type 2 diabetes mellitus
Registration Number
JPRN-jRCTs031180320
Lead Sponsor
Itoh Hiroshi
Brief Summary

Switching from exenatide BID to exenatide QW resulted in reduction in HbA1c, FPG and incidence of hypoglycemia and improvement in beta cell function and treatment satisfaction in patients with T2DM. These findings will be useful for selecting optimal treatment in individuals with T2DM.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
62
Inclusion Criteria

(1) Adult patients with type 2 diabetes mellitus (over 20 years of age)
(2) Patients treated with Byetta (over 12 weeks) (combined use of sulphonylurea, biguanide and/or thiazolidinedione is permissible)
(3) Patients from whom written informed consent for participation is obtained.

Exclusion Criteria

(1) Patients with type 1 diabetes mellitus,
(2) Patients with diabetic ketoacidosis
(3) Patients with diabetic coma and pre-coma
(4) Patients with history of serious hypersensitivity to exenatide or any of its components
(5)Patients who intend to become pregnant, and patients who are pregnant, parturient or lactating
(6) Patients with severe infections
(7) Patients at emergency surgery
(8) Patients with severe renal dysfunction, and patients on dialysis
(9) Any other condition which the attending physician feels would interfere with trial participation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in HbA1c level at week 24
Secondary Outcome Measures
NameTimeMethod
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