A multicenter trial on the effects of oral hypoglycemic agents on beta-cell function in drug-naive type 2 diabetes

JRCT ID: jRCTs051220187

Registered date:09/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 26/05/2023
• Target sample size: 87
• Study type: Interventional
• Intervention(s): The subjects are randomly assigned to one of three groups and treated for 24 weeks: T) Tofogliflozin 20 mg/day, S) oral semaglutide 3, 7 or 14 mg/day and I) imeglimin 2000 mg/day. Randomization will be performed using a dynamic randomization algorithm designed to minimize imbalance in BMI and 75-g oral glucose tolerance test derived disposition index (DI) before treatment. The subjects will undergo a 75-g oral glucose tolerance test at week 25 (after a 1-week wash-out period).

Outcome(s)

• Primary Outcome: Change in Disposition Index (DI: Insulinogenic Index(II)120 min * Matsuda index) at week 25 (after 1-week wash-out period) from baseline

Secondary Outcome

(1) Change in the following other DIs from baseline at week 25:
1.DI2: II 30 min * Matsuda index
2.DI3: II 30 min * 1/Ins0
3.DI4: delta AUCIns0-120 / delta AUCGlu0-120 *
Matsuda index

(2) Change in II 30 min and II 120 min from baseline at week 25

(3) Percentage change in the following DIs from baseline at week 25:
1.DI: II 120 min * Matsuda index
2.DI2: II 30 min * Matsuda index
3.DI3: II 30 min * 1/Ins0
4.DI4: delta AUCIns0-120 / delta AUCGlu0-120 * Matsuda index

(4) Percentage change in II 30 min and II 120 min from baseline at week 25

(5) Change in the following parameters at week 25 from baseline:
1.HbA1C
2.Fasting glucose
3.HOMA-Beta*
*HOMA-beta = (0-min insulin levels*360) / (0-min glucose levels-63)
4. BMI, blood pressure, pulse rate, Hb, TG, LDL-C, HDL-C, UN, Cr, UA, GFR, Na, K, Cl, AST, ALT, gamma-GTP, ALP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged at least 18 years at the time of consent acquisition.
2) Patients with type 2 diabetes requiring medication.
3) Patients who have never been treated with medication for type 2 diabetes.
4) Patients with HbA1c less than 9.0%.
5) Patients who have the capacity to consent and have provided written informed consent.

Exclude criteria

(1) Patients with type 1 diabetes.
(2) Patients requiring insulin therapy (e.g., insulin-dependent, insulin-independent but requiring insulin therapy to correct hyperglycemia, severe ketosis, diabetic coma or pre-coma, severe infection, pre- or postoperative, severe pancreatic disease, severe trauma).
(3) Patients with a history of taking alpha glucosidase inhibitors or SGLT2 inhibitors.
(4) Patients who are pregnant or lactating or may be pregnant or wish to become pregnant during the research period.
(5) Patients with inadequately treated endocrine disorders (e.g., pituitary, adrenal or thyroid disease).
(6) Patients with heart failure symptoms of NYHA functional class III or IV.
(7) Patients with diagnosed or suspected malignancy.
(8) Patients treated with oral or injectable corticosteroids.
(9) Patients with eGFR <45 mL/min/1.72 m^2.
(10) Patients with severe liver disease (AST or ALT > 100 IU/L).
(11) Patients with poorly controlled dysuria due to neurogenic bladder, benign prostatic hyperplasia, etc.
(12) Patients with symptomatic urinary tract infection or genital infection.
(13) Patients with a history of cerebral infarction.
(14) Patients with a history of renal disease, such as nephrectomy, renal transplantation, etc.
(15) Patients who underwent gastrectomy.
(16) Patients who cannot avoid eating, drinking, or taking other medications for at least 30 minutes after waking up.
(17) Patients currently participating in other interventional trials (including clinical trials).
(18) Patients judged as ineligible for participation in this study by the Principal Investigator, Site Principal Investigator or Sub-Investigator.

Related Information

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