Metformin Englazine tablets (Enbipine) for the treatment of type 2 diabetes Central, prospective, observational study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300074612

Enrollment

Unknown

Registered

2023-08-10

Start date

2023-08-12

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

Type 2 diabetes

Interventions

Metformin Englazine tablets treatment group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old, regardless of gender; 2. Clinically diagnosed as type 2 diabetes (refer to the Guidelines for the Prevention and Treatment of Type 2 diabetes in China (2020)); 3. First time receiving treatment with Metformin Engliflozin Tablets (Enshuipin); 4. Within 2 weeks prior to enrollment, there should be a test result of glycated hemoglobin (HbA1c) (which is acceptable for rapid fingertip examination); 5. Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Moderate to severe renal dysfunction (eGFR<45 mL/min/1.73 m2), end-stage renal disease or dialysis; 2.Acute or chronic metabolic acidosis, including diabetic ketoacidosis; 3.Have a history of severe allergy to englaglizin, metformin or any excipient of this product; 4.Participate in any other clinical trial currently or within the past 1 month; 5.The researcher judged that it was not suitable to participate in this study

Design outcomes

Primary

Measure	Time frame
Blood glucose clinical control up to standard rate;	—

Secondary

Measure	Time frame
Change in HbA1c from baseline (3, 6, 12 months);Blood glucose clinical control compliance rate (3, 12 months);Fasting blood glucose (venous blood/fingertip blood), 2h postprandial blood glucose (venous blood/fingertip blood), fasting islets (Homeostasis model assessment-insulin resistance index, Homeostasis Model assessment- Insulin resistance Index, HOMA-IR), islet beta cell function (Homeostasis model assessment-insulin-ß, HOMA-ß), C-peptide change from baseline (3, 6, 12 months);Changes in body weight, body mass index (BMI), waist circumference, and hip circumference from baseline (3, 6, 12 months);Blood pressure control compliance rate (3, 6, 12 months);Blood lipid control up to standard rate (3, 6, 12 months);Changes of other laboratory test indicators (3, 6, 12 months);In patients with type 2 diabetes with cardiovascular disease, echocardiographic indicators (LVEF, LVMI, LVEDV, LVESV, LVEDD, LVESD, E/E ', E/A) Changes (3, 6, 12 months);Quality of Life Assessment (EQ-5D) (6, 12 months);Analysis of patients' drug use (recording dose changes, course of treatment, reasons for drug withdrawal, etc.);	—

Measure

Time frame

Change in HbA1c from baseline (3, 6, 12 months);Blood glucose clinical control compliance rate (3, 12 months);Fasting blood glucose (venous blood/fingertip blood), 2h postprandial blood glucose (venous blood/fingertip blood), fasting islets (Homeostasis model assessment-insulin resistance index, Homeostasis Model assessment- Insulin resistance Index, HOMA-IR), islet beta cell function (Homeostasis model assessment-insulin-ß, HOMA-ß), C-peptide change from baseline (3, 6, 12 months);Changes in body weight, body mass index (BMI), waist circumference, and hip circumference from baseline (3, 6, 12 months);Blood pressure control compliance rate (3, 6, 12 months);Blood lipid control up to standard rate (3, 6, 12 months);Changes of other laboratory test indicators (3, 6, 12 months);In patients with type 2 diabetes with cardiovascular disease, echocardiographic indicators (LVEF, LVMI, LVEDV, LVESV, LVEDD, LVESD, E/E ', E/A) Changes (3, 6, 12 months);Quality of Life Assessment (EQ-5D) (6, 12 months);Analysis of patients' drug use (recording dose changes, course of treatment, reasons for drug withdrawal, etc.);

—

Countries

China

Contacts

Public ContactYanbing Li

The First Affiliated Hospital of Sun Yat-sen University

easd04lyb@126.com+86 139 2511 1691

Outcome results

None listed

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