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A study on the efficacy of prolinal glycine and empagliflozin tablets in treating T2DM and the safety of kidney function based on real-world observations.

A study on the efficacy of prolinal glycine and empagliflozin tablets in treating T2DM and the safety of kidney function based on real-world observations.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109827
Enrollment
Unknown
Registered
2025-09-25
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

T2DM

Interventions

Observation Group:This study is an observational study and does not intervene in clinical diagnosis and treatment. It refers to Chapter 9 of the "Guidelines for the Prevention and Treatment of Diabete

Sponsors

The Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Age between 18 and 70 years old, regardless of gender; (2) Clinically diagnosed with type 2 diabetes (refer to the 'Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition)'); (3) Estimated glomerular filtration rate eGFR <= 89 ml/(min×1.73m^2); (4) Clinical physician's judgment that the patient is suitable for treatment with prandial glucagon-like peptide-1 receptor agonist; (5) Voluntary participation in the study and signing of informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria(1) Moderate to severe renal impairment (eGFR = 3 times the upper limit of normal;(3) Individuals with uncontrolled or poorly controlled hypertension (systolic >= 160 mmHg and/or diastolic >= 100 mmHg);(4) Patients with anemia (generally adult males Hb < 120 g/L, adult females Hb < 110 g/L);(5) Acute or chronic metabolic acidosis, including diabetic ketoacidosis;(6) History of severe allergy to canagliflozin, its excipients, or any component of other SGLT-2 inhibitors;(7) Currently participating in or have participated in any other clinical trials within the last month;(8) Considered unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin (HbA1c);

Secondary

MeasureTime frame
Estimated Glomerular Filtration Rate;Fasting Blood Glucose;Body Mass Index;

Countries

China

Contacts

Public ContactMiao Zhang

The Affiliated Hospital of Guizhou Medical University

miaozchang@qq.com+86 135 9500 8067

Outcome results

None listed

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