Clinical trial NCT07023172: Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
Official title: Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Proline plus empagliflozin tablets
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age ≥18 years, no gender restriction; clinically diagnosed with type 2 diabetes mellitus (per Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus \[2020\]); deemed by investigators as suitable for and initiating empagliflozin treatment for the first time.

Brief summary: This study is a post-marketing, multicenter, prospective, observational study designed to evaluate the efficacy and safety of Proline Plus Empagliflozin Tablets in the real-world clinical treatment of type 2 diabetes mellitus. The study does not interfere with routine clinical practice, and Proline Plus Empagliflozin Tablets may be used either as monotherapy or in combination with other therapeutic agents based on actual clinical needs.

Detailed description: This study is a post-marketing study aimed at evaluating the effectiveness and safety of proline-containing gliflozin tablets in the real-world clinical treatment of type 2 diabetes mellitus. The study is designed as a multicenter, prospective, observational study. This research does not interfere with clinical diagnosis and treatment, and proline-containing gliflozin tablets may be used as monotherapy or in combination with other therapeutic drugs based on actual needs.

Dosage and administration of proline-containing gliflozin tablets:

For newly diagnosed type 2 diabetes patients: The initial dose is one tablet once daily, taken with meals. For patients requiring enhanced glycemic control who tolerate 25 mg once daily, the dose may be increased to 50 mg once daily, taken with meals.

This study includes a screening period (D-14 to D0) and a treatment period (12 weeks ± 7 days, 24 weeks ± 28 days, 48 weeks ± 28 days), totaling 4 visit points. During the study, patients may undergo examinations based on actual clinical needs. The trial requires recording patients' baseline physical examinations, study drug prescription and concomitant medication use, examinations performed according to clinical needs, and the occurrence of adverse events or adverse drug reactions.

The EQ-5D score will be assessed for all subjects. Additionally, for subjects aged 50 years or older (with an education level of elementary school or above), the MoCA (Version 7.1) score and cognitive impairment assessment will be conducted at all visit points except the second one.

Subgroups will be defined based on baseline age (\<65 years, ≥65 years), HbA1c (HbA1c ≥7%, ≥9%, or ≥11%), BMI (BMI \<24.0 kg/m², 24.0 kg/m² ≤ BMI ≤ 28.0 kg/m², BMI ≥28.0 kg/m²), and concomitant medications (number and types of glucose-lowering drugs) to observe differences in efficacy between subgroups.Subgroups will also be defined based on comorbidities to observe the glucose-lowering efficacy and changes in relevant clinical indicators in different comorbidity populations, such as:Chronic kidney disease population: Focus on changes in serum creatinine (SCr), urine protein (Pro), estimated glomerular filtration rate (eGFR), urine albumin-to-creatinine ratio (UACR), and major adverse kidney events (MAKE).Cardiovascular disease population: Focus on major adverse cardiovascular events (MACE) and echocardiographic indicators.

Retinopathy population: Focus on fundus examination results.Cognitive impairment population: Focus on changes in MoCA scores.The analysis indicators will be based on actual analyzable data generated during the study.

Eligibility criteria: Inclusion Criteria:

* 1.Age ≥18 years, regardless of gender. 2.Clinically diagnosed with type 2 diabetes mellitus (per the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus \[2020 Edition\]).

  3.Deemed suitable by the investigator for treatment with proline-containing gliflozin tablets (Hui You Jing) and being prescribed this medication for the first time.

  4.Availability of glycated hemoglobin (HbA1c) test results within 4 weeks prior to enrollment.

  5.Voluntary participation with signed informed consent.

Exclusion Criteria:

- 1.History of moderate to severe renal impairment (eGFR \<30 mL/min/1.73 m²), end-stage renal disease, or dialysis.

2.Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Severe allergy to gliflozin or any excipient of the study drug. 3.Current or recent (within 1 month) participation in any other clinical trial. 4.Investigator judgment of unsuitability for the study.

Primary outcomes:
measure: HbA1c <7.0%
timeFrame: at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
References: