Ruiqin (henagliflozin) / Jiangsu Hengrui Pharma - LARVOL DELTA

Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes—A Multicenter, Randomized, Open-Label, Controlled Study (ADA 2025) - "Addition of henagliflozin to CSII demonstrated superior glycemic control, shorter time taken to achieve the target glucose, and less insulin dosage compared to CSII in patients with T2DM. The overall safety profile of henagliflozin+CSII is consistent with CSII."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Prospective Cohort Study on Changes in the Foveal Avascular Zone in Patients with Type 2 Diabetes and Chronic Kidney Disease with or without Proteinuria Treated with Henggliflozin (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: The First Central Hospital of Baoding; The First Central Hospital of Baoding

New trial • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A study on Efficacy and Safety of SGLT-2 Inhibitors Combined with Finerenone in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease (ChiCTR) - P4 | N=1425 | Not yet recruiting | Sponsor: The first medical center of Chinese PLA general hospital; Southeast University Affiliated Zhongda Hospital

New P4 trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A randomized controlled study of Henagliflozin in type 2 diabetes mellitus with cardiac autonomic neuropathy (ChiCTR) - P4 | N=94 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital; Guangdong Provincial People's Hospital

New P4 trial • Diabetes • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

Effect of Henagliflozin on cardiac function and structure in HFpEF patients with combined type 2 diabetes mellitus (ChiCTR) - P4 | N=40 | Not yet recruiting | Sponsor: Department of Cardiovascular Medicine, Hubei Third People's Hospital; Hubei NO. 3 People’s Hospital

New P4 trial • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Achieving comprehensive control targets with glucose-lowering regimens containing henagliflozin or fixed-dose combinations in adults with type 2 diabetes mellitus: a real-world, multicenter registry study (ChiCTR) - P4 | N=2000 | Not yet recruiting | Sponsor: Hunan Provincial People's Hospital; Hunan Provincial People's Hospital

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients with New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study (clinicaltrials.gov) - P4 | N=268 | Not yet recruiting | Sponsor: Zhejiang Provincial People's Hospital

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=181 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment closed • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM (clinicaltrials.gov) - P4 | N=210 | Completed | Sponsor: First Affiliated Hospital of Guangxi Medical University | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Oct 2024 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of 11 sodium-glucose cotransporter-2 inhibitors at different dosages in type 2 diabetes mellitus patients inadequately controlled with metformin: a Bayesian network meta-analysis. (PubMed, BMJ Open) - "As add-on therapy, SGLT2is demonstrated favourable antidiabetic efficacy and acceptable safety. 300 mg of canagliflozin was the best option among the included interventions considering favourable glucose control and WL. Some novel SGLT2is (eg, henagliflozin) exhibited promising efficacy and safety profiles, but more research is needed to validate the findings."

Clinical • Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

HOLIDYA: The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy (clinicaltrials.gov) - P4 | N=64 | Not yet recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluation and comparison of efficacy and safety of tirzepatide, liraglutide and SGLT2i in patients with type 2 diabetes mellitus: a network meta-analysis. (PubMed, BMC Endocr Disord) - "Out of the seven medications examined in this study, tirzepatide demonstrates the most effective antidiabetic and weight-reducing effects. Furthermore, the dosage of Liraglutide at 1.2 mg and above demonstrates a more pronounced hypoglycemic effect in comparison to SGLT2 inhibitors. SGLT2 inhibitors exhibit a distinct hypotensive effect and are suitable for diabetic individuals experiencing hypertension."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

Randomized controlled trial of the efficacy and safety of Henagliflozin in lowering uric acid in type 2 diabetes patients with hyperuricemia (ChiCTR) - P4 | N=290 | Recruiting | Sponsor: The Affiliated Hospital Of Qingdao University; The Affiliated Hospital of Qingdao University | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Efficacy and Mechanism of Early Intervention with Ketogenic Diet in Type 2 Diabetic Nephropathy (ChiCTR) - P=N/A | N=100 | Sponsor: Affiliated Hospital of Southwest Medical University; Affiliated Hospital of Southwest Medical University

New trial • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Henagliflozin on Liver Fibrosis in Patients with MASLD and T2DM (clinicaltrials.gov) - P4 | N=190 | Not yet recruiting | Sponsor: Xiqiao Zhou

New P4 trial • Diabetes • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion in the treatment of Chinese inpatients with type 2 diabetes mellitus based on a continuous glucose monitoring system: protocol of a multicentre, open-label, inpatient, randomised, controlled trial. (PubMed, BMJ Open) - P4 | "The study will be disseminated through peer-reviewed publications and conference presentations. NCT05677334."

Clinical • Clinical protocol • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A randomized controlled study of proline hengaricin tablets for the treatment of type 2 diabetes mellitus and prevention of early progression of diabetic kidney disease (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Guangdong Hospital of Traditional Chinese Medicine; Guangdong Hospital of Traditional Chinese Medicine

New P4 trial • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Henagliflozin for the overweight or obese patients with type 2 diabetes and heart failure: a multicenter, randomized, double-blind, controlled trial (ChiCTR) - P4 | N=778 | Not yet recruiting | Sponsor: the First Affiliated Hospital of University of Science and Technology of China; The First Affiliated Hospital of University of Science and Technology

New P4 trial • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Sodium-glucose cotransporter 2 inhibition through henagliflozin ameliorates cognitive impairment in patients with type 2 diabetes. (PubMed, J Diabetes Investig) - "Henagliflozin treatment was independently associated with improvements in Montreal Cognitive Assessment scores and plasma phosphorylated tau181 levels, indicating significant beneficial effects on cognitive impairment in patients with type 2 diabetes."

Journal • Alzheimer's Disease • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of henagliflozin on left ventricular mass index in dialysis patients with HFpEF (HELD-HF): protocol for a multicentre, randomised, double-blind, placebo-controlled trial. (PubMed, BMJ Open) - "Both positive and negative results will be reported. ChiCTR2300073169."

Clinical protocol • Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease

HHTN: Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Zhujiang Hospital

New P4 trial • Diabetes • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Henagliflozin's Impact on Prediabetes Remission (clinicaltrials.gov) - P4 | N=984 | Not yet recruiting | Sponsor: Shandong Provincial Hospital

New P4 trial • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluation of Drug-Drug Interaction Between Henagliflozin and Hydrochlorothiazide in Healthy Chinese Volunteers. (PubMed, Drug Des Devel Ther) - P1 | "Given these results, coadministration of HCTZ should not require any adaptation of henagliflozin dosing. ClinicalTrials.gov NCT06083116."

Journal

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Peking University First Hospital

Combination therapy • New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus