Overweight patients with type 2 diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Japan society for Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria are included. 1. A Japanese patient with type 2 diabetes mellitus who underwent treatment with an antidiabetic drug other than an SGLT2 inhibitor for 3 months (12 weeks) or longer in addition to diet and exercise therapies, and has not accomplished the goal in glycemic control defined in the Diabetes Treatment Guide 2014-2015 (HbA1c [NGSP] value of 7.0% or higher and less than 9.0%) 2. A patient who newly starts using dapagliflozin in addition to their antidiabetic drug(s) prescribed before the study, in line with recommendations by the Japan Diabetes Society 3. A patient with BMI >25 4. A patient with eGFR >45 ml/min 5. A male or female who is at or older than 20 years of age but younger than 60 years of age, at the time of consenting 6. A patient who has consented in writing to participate in the study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. QOL score change in OHA-Q 2. Correlation between changes in HbAlc and body weight and change in OHA-Q score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakayama Hiroki
Soiken Inc. Patient Reported Outcome study research support center
Outcome results
None listed