Tofogliflozin, an SGLT2 Inhibitor, versus Glimepiride, a sulfonylurea, Hypoglycemic agent Trial to compare the Effect on skeletal muscle mass in Non-obese patients with type 2 diabetes mellitus; multicenter, open-label, randomized-controlled trial

JRCT ID: jRCTs041240011

Registered date:10/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 18/04/2024
• Target sample size: 56
• Study type: Interventional

Intervention(s)

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 glimepiride for 24 weeks (+/- 4 weeks) according to the dose and usage described in its package insert

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kumashiro Naoki
• Source(s) of Monetary Support: Kowa Company, Ltd.