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iraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial

Not Applicable
Conditions
Type 2 diabetes mellitus
Registration Number
JPRN-UMIN000007009
Lead Sponsor
Yokohama City Unuversity Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry. 2. Patients with during pregnancy or lactation. 3. severe infection, before operation, severe trauma 4. Patients who received steroid therapy 5. Patients with history of cardiac failure. 6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min). 7. Patients with severe liver dysfunction. 8. Patients with type1 diabetes. 9. Patients with disorder of insulin secretion (serum C-peptide < 0.5ng/ml) 10. Patients who are hypersensitive to these medicines 11. Patients judged to be inappropriate by physicians in charge.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
HbA1c at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir.
Secondary Outcome Measures
NameTimeMethod
Fasting plasma glucose and self-monitoring blood glucose and body weight at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir , Diabetes treatment satisfaction questionnaire (DTSQ) , Frequency of side effects (digestive symptoms, hypoglycemia)
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