Type 2 DiabetesNCT07023172
Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
An observational study of Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- 30 May 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
Bi Yan, 86+13655176388, biyan@nju.edu.cn
Ge Zhi Juan, 86+18061758651, gzjyunduan@126.com
- Recruiting
Xinyang Central Hospital
Xinyang, Henan, 464000
Shen Hongmei Shen Hongmei, Master Degree Candidate, 19837622007, 48762111@qq.cn
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Proline plus empagliflozin tablets
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c <7.0%
Glycemic control rate at 24 weeks, where glycemic control is defined as HbA1c <7.0%
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 May 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023172
- Sponsor's protocol ID
- HDHYJ-LC-1
- Status last verified
- May 2025
- First submitted
- 6 Jun 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Observational Study on the Treatment of Type 2 Diabetes With Proline Plus Empagliflozin Tablets
- ClinicalTrials.gov ID
- NCT07023172
- Acronym / sponsor ID
- HDHYJ-LC-1
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Proline plus empagliflozin tablets
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c <7.0%
Time frame: at 24 weeks
Glycemic control rate at 24 weeks, where glycemic control is defined as HbA1c <7.0%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bi Yan (86+13655176388, biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c <7.0% (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.