NCT07023172

Recruiting

Multicenter, Prospective, Observational Study on the Treatme...

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source

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Other study identifiers

Sponsor study identifier

HDHYJ-LC-1

Study Type

observational

Estimated enrollment

3,000

Locations

1 country

Sites

2

Timeline

Study Start

May 30, 2025

Actual (reported)

Primary Completion

October 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

October 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 3,000 participants
Study completion date: October 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 30, 2025
Actual (reported)
First Submitted
June 6, 2025
Actual (reported)
First Posted
June 15, 2025
Actual (reported)
Primary Completion
October 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: February 5, 2026
Status Verified: May 2025
Last Update Submitted: February 4, 2026

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesProline plus empagliflozin tablets

Outcome Measures

Primary Outcomes (1)

HbA1c <7.0%
Glycemic control rate at 24 weeks, where glycemic control is defined as HbA1c \<7.0%
at 24 weeks

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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 \[2020 Edition\]).

Sponsors & Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Otherlead

Study Sites (2)

Xinyang Central Hospital

Xinyang, Henan, 464000, China

RECRUITING

Shen Hongmei Shen Hongmei, Master Degree CandidateCONTACT19837622007 48762111@qq.cn

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210000, China

RECRUITING

Bi YanCONTACT86+13655176388

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Bi Yan

CONTACT

86+13655176388 biyan@nju.edu.cn

Ge Zhi Juan

CONTACT

86+18061758651

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 15, 2025

Study Start

May 30, 2025

Actual (reported)

Primary Completion

October 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

NCT06495931

Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human

Phase 1Completed

NCT06481085

To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

Phase 2Completed

NCT07374328

Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus

Phase 1/2Recruiting

NCT07801820

Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus

Phase 2Recruiting

NCT07163624

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

Phase 2Completed

NCT06778967

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

Phase 3Active Not Recruiting

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

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

Voluntary participation with signed informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

biyan@nju.edu.cn

Ge Zhi JuanCONTACT86+18061758651 gzjyunduan@126.com

Bi YanPRINCIPAL INVESTIGATOR

gzjyunduan@126.com

Study Completion

October 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

February 5, 2026

Record last verified: 2025-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07023172
Data provider: ClinicalTrials.gov
Source updated: 2026-02-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:04 UTC

Locations

CN(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations