JPRN-UMIN000016304
Completed
N/A
Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus - PRO study
Japan society for Patient Reported Outcome0 sites220 target enrollmentJanuary 23, 2015
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight patients with type 2 diabetes mellitus
- Sponsor
- Japan society for Patient Reported Outcome
- Enrollment
- 220
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients who meet any of the following criteria are excluded from the study subjects. 1\. A patient who is not using an antidiabetic drug at the time of consenting 2\. A patient with a history of severe hypoglycemia within a year 3\. A patient with type 1 diabetes mellitus or secondary diabetes mellitus 4\. A patient with severe infection, a pre or postsurgical patient, and a patient with serious trauma 5\. A patient with a history of MI (myocardial infarction), AP (angina), or CI (cerebral infarction) 6\. A patient with atrial fibrillation or frequent ventricular premature contraction 7\. A patient with moderate or severe heart failure (a patient at stage 3 or a higher stage of the NYHA/New York Heart Association classification) 8\. A patient with moderate renal dysfunction (serum creatinine in mg/dL: male, 1\.4 \< female, 1\.2 \<) 9\. A patient with severe liver dysfunction (AST 100 IU/l or higher) 10\. A patient with ascites retention, and a patient with a brain disorder 11\. A patient with unstable hypertension or unstable dyslipidemia within 12 weeks before consenting 12\. A patient with alcohol or drug dependence 13\. A patient who is pregnant or breast\-feeding, suspected of being pregnant, or has a plan to get pregnant 14\. A patient with dementia 15\. A patient who meets a contraindication of the study drug 16\. A patient who is using insulin and GLP\-1, and a patient who is routinely using injectors 17\.A patient conditions deemed inappropriate by an investigator in charge
Outcomes
Primary Outcomes
Not specified
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