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Efficacy and safety of metformin in combination with polyethylene glycol loxenatide and canagliflozin in high-risk secondary prophylaxis patients with type 2 diabetes and kidney disease

Efficacy and safety of metformin in combination with polyethylene glycol loxenatide and canagliflozin in high-risk secondary prophylaxis patients with type 2 diabetes and kidney disease: a prospective, multicenter, randomized controlled, open-label study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045569
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-29

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:Metformin + PEX-168 + canagliflozin
Control group:Metformin + canagliflozin

Sponsors

Tianjin Medical University Zhu Xian Yi Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 yearsat the time of signing the informed consent, 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 >= 24 Kg/ m^2 ; 6 eGFR: above 60mL/min/ 1.73m2; 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

MeasureTime frame
glycated hemoglobin;

Secondary

MeasureTime frame
fasting blood glucose;blood routine;blood biochemistry;urine routines;urinalysis;height;weight;waist;

Countries

China

Contacts

Public ContactChen Liming

Tianjin Medical University Zhu Xian Yi Memorial Hospital

xfx22081@vip.163.com+86 22 59560475

Outcome results

None listed

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