Type 2 diabetes mellitus
Conditions
Interventions
Group to use SGLT2 inhibitor (Tofogliflozin)
- administer tofogliflozin for 24 weeks (+/- 4 weeks) according to the dose and usage described in its package insert
Group to use SU
- administer glimep
Sponsors
Kumashiro Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study: 1) Patients whose BMI is less than 25 kg/m2 at eligibility determination 2) Patients who is diagnosed with type 2 diabetes mellitus 3) Patients who do not use SU or SGLT2 inhibitor for at least 6 weeks prior to eligibility determination 4) Patients who do no add or change dose of DPP-4 inhibitor or GLP-1 recepror agonist for at least 6 weeks prior to eligibility determination 5) Patients whose HbA1c is 7.0% or higher and less than 10.0% 6) Outpatients 7) Patients who are 20 years or older at giving their consent 8) Patients who give their consent in written form by their free will (patients who require legal representative are excluded) *The eligibility is determined on the date of giving their consent. Regarding HbA1c and BMI, data within 8 weeks prior to giving their consent can be used for the eligibility determination.
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study: 1) Patients with contraindications to SGLT2 inhibitors 2) Patients with contraindications to SUs 3) Patients with type 1 diabetes mellitus or diabetes caused by other specific mechanisms or diseases 4) Patients with diabetic ketoacidosis 5) Patients with history of severe hypoglycemic symptoms with coma or loss of consciousness 6) Patients with severe infections, before or after surgery, or severe trauma 7) Patients with severe renal impairment (eGFR < 30 ml/min/1.73m2), liver cirrhosis, or heart failure 8) Patients with profiferative retinopathy or maculopathy requiring immidiate treatment 9) Patients who are treated with malignancy or unstable collagen disease 10) Patients who are breastfeeding, pregnant or possibly pregnant 11) Patients with serious complications, and whom physician judge inapproprite to participate in this study due to the complications 12) Patients with other conditions that the responsible investigator or sub investigators judge inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total skeletal muscle mass/total body weight ratio from baseline to 24 weeks after the inititation of study agent or control agent *Total skeletal muscle mass is determined as total lean body mass in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent change in total skeletal muscle mass/total body weight ratio from baseline to 24 weeks after the inititation of study agent or control agent 2. Change or percent change in skeletal muscle mass index (SMI) from baseline to 24 weeks after the inititation of study agent or control agent 3. Change or percent change in total skeletal muscle mass/total fat mass ratio, total fat mass/total body weight ratio, and fat mass% from baseline to 24 weeks after the inititation of study agent or control agent 4. Change or percent change in nutrient intake (carbohydrate (g/day), lipid (g/day), protein (g/day), and sucrose (g/day)) or energy intake (kcal/day) measured by BDHQ from baseline to 24 weeks after the inititation of study agent or control agent 5. Change or percent change in other parameters (other parameters in DXA or general blood tests) from baseline to 24 weeks after the inititation of study agent or control agent 6. Correlations between change in total skeletal muscle mass/total body weight ratio or change in SMI from baseline to 24 weeks after the inititation of study agent or control agent and other parameters above or patients' characteristics 7. Frequency of adverse event or disease-or-the-like | — |
Contacts
Public ContactNaoki Kumashiro
Kanazawa Medical University
Outcome results
None listed