Patient Reported Outcome study of Dapagliflozin on glycemic control and treatment satisfaction in overweight patients with type 2 diabetes mellitus

Not Applicable

• Conditions: Overweight patients with type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000016304
• Lead Sponsor: Japan society for Patient Reported Outcome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. QOL score change in OHA-Q 2. Correlation between changes in HbAlc and body weight and change in OHA-Q score

Secondary Outcome Measures

Name	Time	Method
1. Changes in index values related to glycemic control: HbA1c and fasting blood glucose level 2. Changes in body weight, BMI, and abdominal circumference 3. Changes in index values related to the body composition: Fat mass, muscle mass, and bone mass 4. Changes in index values related to lipid metabolism (TC, HDL-C, TG, LDL-C*) *LDL-C is obtained by calculation. 6. Safety-related indices, and the incidence of adverse events