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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-jRCTs051220187
• Lead Sponsor: Furukawa Yasushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 87

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified