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NCT06417489Not yet recruiting

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

Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin Compared to Sequential Metformin Therapy in Newly Diagnosed Type 2 Diabetes Patients
Peking University First HospitalPhase 4ClinicalTrials.govdrug
Study focus
Disease/Condition
Type 2 Diabetes
Drug/Device/Intervention
Combination therapy
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Peking University First Hospital
Timeline & enrollment
Phase
Phase 4
Start date
May 31, 2024
End date
Dec 31, 2026
Enrollment
160 participants
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
Type 2 diabetes mellitusType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06417489
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06417489 through Pure Global AI's free database. This Phase 4 trial is sponsored by Peking University First Hospital and is currently Not yet recruiting. The study focuses on Type 2 Diabetes. Target enrollment is 160 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.