Efficacy and safety of Polyethylene Glycol Loxenatide in combination with Canagliflozin in patients with type 2 diabetes mellitus at high risk for secondary prevention of heart and kidney disease

Efficacy and safety of Polyethylene Glycol Loxenatide in combination with Canagliflozin in patients with type 2 diabetes mellitus at high risk for secondary prevention of heart and kidney disease: a prospective, multicenter, randomized controlled, open-label study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045608

Enrollment

Unknown

Registered

2021-04-19

Start date

2021-04-20

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

experimental group:Polyethylene Glycol Loxenatide + Canagliflozin

control group:Metformin+ Canagliflozin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years at the time of signing the informed consent and no gender limits; 2. The subjects voluntarily agree to participate and sign the informed consent; 3. Diagnosis of type 2 diabetes mellitus (WHO1999 criteria); 4. Oral drug treatment is not up to standard, HbA1c 7-10%; 5. BMI of 22.5 Kg/m^2 or higher; 6. eGFR: 30-90 mL/min/1.73 m2; and UACR: > 300 mg/g (passed twice continuously); 7. Previous cardiovascular and cerebral events.

Exclusion criteria

Exclusion criteria: 1. Blood transfusion or severe blood loss or known hemoglobinopathy, hemolytic anemia or sickle cell anemia or any other condition that interferes with the determination of HbA1c 3 months prior to the first visit; 2. Have been diagnosed or had previous diabetes acute complications (such as diabetic ketoacidosis, hyperglycemia and hyperosmolarity in the past 6 months); 3. Major cardiovascular history during the first 3 months was screened, which was defined as: myocardial infarction, coronary angioplasty or bypass grafting, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident; 4. In the previous 3 months, patients had been treated with sodium-glucose cotransporter 2 inhibitor (SGLT2I) and glucagon-like peptide 1 receptor agonist (GLP-1RA); 5. Any other conditions (such as known drug abuse, alcohol abuse, mental illness, etc.) that may prevent patients from following and completing the trial protocol; 6. Pregnant or lactating women; 7. Fasting blood glucose 265 µmol/L, symptomatic hypotension (5.5 mmol/L); 9. An additional intervention study is currently being undertaken.

Design outcomes

Primary

Measure	Time frame
HbA1c;	—

Secondary

Measure	Time frame
fasting blood glucose;blood routine;blood biochemistry;urine routines;urinalysis;height;weight;waist;	—

Countries

China

Contacts

Public ContactTong Nanwei

West China Hospital Sichuan University

tongnw@scu.edu.cn+86 28 85553329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026