Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients - Trial NCT06417489

Timeline & Enrollment

Primary Outcome

Proportion of subjects with HbA1c7% at 12w

Summary

This study evaluated the efficacy and safety of initial combined treatment of Henggliptin,
 Retagliptin and Metformin by including new type 2 diabetes patients. This study is a
 multicenter, randomized, open label, positive control study. It is planned to include 160 new
 type 2 diabetes patients who meet the inclusion criteria of the study. The study is divided
 into three stages: screening period (V0, -14d-0), treatment period (V1-V8, D1-24w) and safe
 follow-up period (V9, 28w), with a total of 10 planned visits. This study was divided into an
 experimental group and a control group. The experimental group received a one-time addition
 of 10 mg qd of Henggliptin, 100 mg qd of Regagliptin, and 500mg of Metformin. The control
 group was first treated with metformin. If the blood sugar level did not meet the standard
 (fasting blood glucose (FPG)7mmol/L, postprandial blood glucose (PPG)10mmol/L),
 Henggeliflozin 10 mg qd was sequentially added. If the blood sugar level did not meet the
 standard after 4 weeks, Regagliptin 100 mg qd was added. During the follow-up period,
 evaluate blood glucose control, pancreatic islet function, and safety in both groups of
 patients.

ICD-10 Classifications