CANONICAL study

Not Applicable

• Conditions: Heart failure with preserved ejection fraction in type 2 diabetes mellitus; type 2 diabetes,heart failure

• Registration Number: JPRN-jRCTs051180030
• Lead Sponsor: Saito Yoshihiko

Brief Summary

In this study, 82cases were the maximum analyzed cases (canagliflozin group [Group A: 42 cases], and standard therapy group [Group B: 40 cases]). There were no significant differences in clinical characteristics between the two groups. In the primary endpoints, body weights were significantly decreased after 24 weeks compared with the baseline values in group A alone, whereas there were no significant changes in BNP of both groups. The incidence of adverse events was similar in the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-24
• Study Completion: 2020-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

1. Patients providing written informed and consent to participate in the study
2. Aged >= 65 years (irrespective of sex)
3. HbA1c >= 6.5%, and HbA1c <10.0% within 8 weeks. HbA1c >= 7.0% in case of administration of sulfonylurea, and/or glinide
4. History of heart failure before consent, and echocardiographic mean E/e' >14 (septal E/e' >15, or lateral E/e' >13 ) , or septal e' <7 cm/min, or lateral e' <10 sec/min and LV ejection fraction >= 50%, with or without atrial fibrillation (AF)
5. Plasma BNP >= 100 pg/mL or plasma NT-proBNP >= 400 pg/mL before consent, or plasma BNP >= 40 pg/mL or plasma NT-proBNP >= 125 pg/mL within 8 weeks before consent, with or without atrial fibrillation (AF)
6. NYHA cardiac function classification of II-III within 8 weeks prior to the date of informed consent
7. Patients who have not changed the dosage and administration of antidiabetic drugs and heart failure drugs from at least 8 weeks before the date of informed consent

Exclusion Criteria

1. Type 1 diabetes
2. Patients treated with a glucagon-like peptide-1 (GLP-1) receptor agonists
3. Need insulin therapy for blood glucose management (e.g., patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, severe trauma)
4. Severe renal dysfunction or chronic renal failure during dialysis (In case of moderate renal dysfunction, patients are carefully judged the need for administration of canagliflozin)
5. History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent,
6. NYHA cardiac function classification of IV
7. BMI <18.5 kg/m2
8. Pregnant, breast-feeding, or possibly pregnant women
9. Diagnosed or suspected malignant tumors (Patients who did not treat anti-cancer treatment within 1 year before consent can be entered.)
10. Patients who were judged by the investigator to be inappropriate for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified