PROTECT

Phase 4

• Conditions: Type2 diabetes

• Registration Number: JPRN-jRCTs071180041
• Lead Sponsor: ode Koichi

Brief Summary

A total of 482 subjects were equally randomized to the ipragliflozin and control groups. Changes of the mean CCA-IMT for 24 months, which was the primary endpoint, was 0.0013 mm in the ipragliflozin group, and 0.0015 mm in the control group, and the estimated between-group difference(ipragliflozin group-control group) was -0.0001mm (P=0.989). These results suggest that 24-month treatment of ipragliflozin, compared to conventional therapy, in patients with type 2 diabetes had no impact on the CCA-IMT.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Study Completion: 2020-12-24
• Results First Posted: 2022-10-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and less than10.0% despite diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for over three months
2)over 20 years of age at the time of informed consent acquisition and hospitalization or outpatient
3) The patient provided with information about the study,submitted written informed consent to it

Exclusion Criteria

1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma within 6 months
3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation)
4) With severe renal dysfunction (eGRF <45 mL/min/1.73m2 or patient undergoing artificial dialysis)
5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage and transient ischemic attacks within 3 months before initiation of the study
6) Heart failure patient whose NYHA functional classification is III or IV
7) Has history of administration of SGLT-2 within 1 month before initiation of the study
8) Pregnant, possibly pregnant, planned to become pregnant or nursing women
9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Are considered not eligible for the study by the attending doctor due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean IMT of common carotid artery from baseline to month 24