Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417489
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Brief Title:
Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 FPGgt7mmolL postprandial blood glucose PPGgt10mmolL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None