NCT04667143

Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy

A Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein Added to Metformin Compared to Retagliptin or Henagliflozein in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Retagliptin, Henagliflozein, metformin XR	Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2020-12-14
• Last updated: 2020-12-14