Ruizetang (retagliptin) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Comparative Analysis of Efficacy, Medication Adherence and Safety Between Henagliflozin Proline, Retagliptin Phosphate and Metformin Hydrochloride Sustained-release Tablets and Triple Antidiabetic Regimen in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control after Dual Oral Therapy (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

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

Efficacy and Safety of Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets in Chinese Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

Effects of Retagliptin Phosphate on BMD and bone metabolism markers in elderly female patients with type 2 diabetes mellitus (ChiCTR) - P=N/A | N=86 | Not yet recruiting | Sponsor: The Fifth Affiliated Hospital of Sun Yat-sen University; The Fifth Affiliated Hospital of Sun Yat-sen University

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

The clinical study on the effect of Retagliptin on serum biomarkers of T2DM-related cognitive impairment (ChiCTR) - P=N/A | N=70 | Not yet recruiting | Sponsor: Affiliated Hospital of Xuzhou Medical University; Affiliated Hospital of Xuzhou Medical University

Biomarker • New trial • Alzheimer's Disease • Cognitive Disorders • Type 2 Diabetes Mellitus

Safety and efficacy of Retagliptin in Chinese patients with type 2 diabetes. (ChiCTR) - P=N/A | N=2500 | Recruiting | Sponsor: The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university

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

Evaluation of efficacy and safety of combination therapy of Henggligin, Retagliptin and Metformin in new type 2 diabetes patients (ChiCTR) - P4 | N=160 | Sponsor: Peking University First Hospital; Peking University First Hospital

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

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

Combination of retagliptin and henagliflozin as add-on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double-blind, active-controlled, phase 3 trial. (PubMed, Diabetes Obes Metab) - "For patients with type 2 diabetes mellitus inadequately controlled by metformin monotherapy, the co-administration of retagliptin and henagliflozin yielded more effective glycaemic control through 24 weeks compared with the individual agents at their corresponding doses."

Clinical • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Retagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial. (PubMed, Diabetes Obes Metab) - "Retagliptin 100 mg QD as an add-on therapy to metformin offers a new therapeutic option for treating Chinese patients with T2D inadequately controlled by metformin alone, and is generally well tolerated."

Clinical • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

A Trial of SP2086 With Hepatic Insufficiency (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Hepatitis C • Liver Failure • Metabolic Disorders

Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes (clinicaltrials.gov) - P3 | N=174 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Dec 2023 | Trial primary completion date: Nov 2022 ➔ Dec 2023

Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

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

High-throughput bioanalysis of sitagliptin in plasma using the Direct Analysis in Real Time mass spectrometry and its application in the pharmacokinetic study thereof. (PubMed, J Sep Sci) - "Sitagliptin and its internal standard retagliptin were detected in positive ion mode by multiple reaction monitoring transitions at m/z 408.2→235.0 and 465.2→260.1 respectively. This method has been successfully applied to the pharmacokinetic study of sitagliptin after single intravenous administration in rats. This approach shows considerable promise of Direct Analysis in Real Time tandem mass spectrometry method in the high-throughput bioanalysis."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes (clinicaltrials.gov) - P3; N=160; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy (clinicaltrials.gov) - P3; N=760; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • Combination therapy • Monotherapy • New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of SP2086 as monotherapy in patients with type 2 diabetes (clinicaltrials.gov) - P3, N=450; Sponsor: Jiangsu HengRui Medicine; Recruiting; New P3 trial.

New P3 trial • Diabetes

The Drug-drug Interaction of SHR3824 and SP2086 (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial primary completion date: Oct 2015 ➔ Jul 2015

Trial primary completion date • Biosimilar • Diabetes

The Drug-drug Interaction of SP2086 and Simvastatin (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Biosimilar • Diabetes