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The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administratio

Not Applicable
Conditions
Type 2 diabetes mellitus
Registration Number
JPRN-UMIN000010176
Lead Sponsor
Shimane University Faculty of Medicine
Brief Summary

The baseline characteristics of subjects, including age, dose of insulin injections, or HbA1c levels, did not differ between the two groups. In the vildagliptin group, HbA1c levels significantly decreased and the significance of HbA1c reduction was maintained for 24 months (from 8.0% to 7.4%, p<0.05, at the end of observational period). In addition, the dose and number of insulin injections significantly reduced (-5.6 units, p<0.01, and -0.9 times, p<0.001). However, these parameters were unchanged in the control group. The number of patients who experienced three or more episodes of hypoglycemia per year was significantly lower in the vildagliptin group (n=4) than in the control group (n=11) (odds ratio, 0.28; 95% confidence interval, 0.08-0.97; p<0.05).

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
400
Inclusion Criteria

Not provided

Exclusion Criteria

type 1 diabetes mellitus, severe liver injury, heart failure, pancreatitis, ileus

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma glucose, HbA1c, diabetic retinopathy, diabetic nephropathy, cardiovascular disease, cerebral infarction, fracture, cancer
Secondary Outcome Measures
NameTimeMethod
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