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The effects of vildagliptin in addition to insulin on glycemic control in hemodialysis patients with type 2 diabetes mellitus

Not Applicable
Conditions
type 2 diabetes mellitus undergoing hemodialysis
Registration Number
JPRN-UMIN000010703
Lead Sponsor
Saiseikai Kumamoto Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1) Severe ketosis, or diabetic coma or precoma, type1 diabetes 2) Severe liver dysfunction 3) Diarrhea or vomiting 4) Severe infection, before and after surgery, or severe trauma 5) History of lactic acidosis or pancreatitis 6) Severe cardiac or pulmonary dysfunction, such as shock, heart failure, myocardial infarction, and pulmonary embolism. 7) Dehydration 8) History of severe alcoholic abuse 9) Malnutrition, starvation, debility, pituitary dysfunction, and adrenal insufficiency 10) Pregnant female, female with possibility of pregnancy 11) Malignancy 12) History of hypersensitivity to targeted medication 13) Patients inappropriate for medical reason

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total daily dose of insulin and HbA1c(NGSP) at 0, 12 and 24 weeks after administration of vildagliptin Mean amplitude of glycemic excursions Safety and adherence
Secondary Outcome Measures
NameTimeMethod
Events of hypoglycemia Body weight
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