Type 2 diabetes
Conditions
Interventions
Interventions group: Conventional treatment + Dapagliflozin [5 mg/day] (On or after week 12, if HbA1c was >
7.5% and there were no safety concerns, dapagliflozin would be up-titrated to 10 mg/day.)
Control group: Conventional treatment (On or after week 12, if HbA1c was >
7.5% and there were no safety concerns, intensification of treatment would be undertaken [up-titration of the medicine, administration of another medicine etc.].)
Sponsors
National Hospital Organization Kyoto Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatient 2. BMI: more than 22 kg/m2 3. HbA1c(NGSP): 6.5% to less than 9.0% 4. Subject have a diet and exercise therapy 5. Subject have SU/MET/alpha-GI/DPP-IV inhibitor or their combinations
Exclusion criteria
Exclusion criteria: 1.Subjects with secondary obesity associated with endocrine disorders 2.Type 1 diabetes mellitus 3.Subjects with severe ketosis, diabetic coma or precoma 4.Subjects with severe infection, before and after surgery or severe injury 5.Subjects with severe hepatic dysfunction 6.Subjects with moderate or more of renal dysfunction (serum creatinine >= 1.5mg/dl[male], 1.3mg/dl[female]). 7.The subjects within the past 6 months, developed stroke, myocardial infarction, or other serious vascular complications requiring hospitalization 8.Subjects with dehydration, diarrhea, vomiting or gastrointestinal injury 9.Subjects in SGLT-2 inhibitors, insulin formulation, GLP-1 receptor agonist prescription 10.Subjects in TZD, fibrate prescription 11.Subjects in pregnant women, lactating women, the potential or planned are pregnant 12.Subjects with a history of hypersensitivity to SGLT-2 inhibitor 13.Subjects who have been determined to be unsuitable for the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum FGF21 level (At 0, 12 and 24 weeks after administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose, body weight, waist circumference, blood pressures, visceral fat mass, subcutaneous fat mass, CAVI, leptin, adiponectin, hs-CRP, muscle thickness of six sites of the body using B-mode ultrasound, skeletal muscle mass, % fat, total body water weight ratio, lean body mass, basal metabolic rate, and serum other miokines (myostatin, irisin, IL-6) | — |
Countries
Japan
Contacts
Public ContactNoriko Satoh-Asahara
National Hospital Organization Kyoto Medical Center Division of Diabetic Research,Clinical Research Institute
Outcome results
None listed