JPRN-jRCTs011230006
Recruiting
Phase 4
Effect of initial treatment with tofogliflozin or metformin on pancreatic beta-cell function in subjects with drug-naive type 2 diabetes -A multicenter, prospective, open-label, parallel-group, randomized, comparative study
akamura Akinobu0 sites70 target enrollmentMay 9, 2023
ConditionsType 2 diabetes
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- akamura Akinobu
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age 20\-90 years old
- •2\) HbA1c 6\.5\-9\.0% and urine ketone negative
- •3\) Patients with type 2 diabetes who have not been taking any hypoglycemic agents more than 3 months
- •4\) Written informed consent
Exclusion Criteria
- •1\) History of anaphylaxis of tofogliflozin
- •2\) History of anaphylaxis of metformin
- •3\) History of lactic acidosis
- •4\) Unstable retinopathy
- •5\) Severe hepatic, renal, or cardiac dysfunction
- •6\) Pregnancy or possibly pregnant females
- •7\) Severe ketosis, diabetic coma
- •8\) Severe infection, surgery, serious trauma
- •9\) Deficiency of insulin secretion
- •10\) Dehydration or possibly dehydration
Outcomes
Primary Outcomes
Not specified
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