Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
NCT07019012 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-06-13
Summary
This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.
Conditions
- T2DM
Interventions
- DRUG
-
SGLT2i+Metformin+Cofrogliptin
The combination of SGLT2i+Metformin+Cofrogliptin
- DRUG
-
SGLT2i+Metformin+Linagliptin
The combination of SGLT2i+Metformin+Linagliptin
Sponsors & Collaborators
-
Renmin Hospital of Wuhan University
collaborator OTHER -
Wuhan Central Hospital
collaborator OTHER -
Taihe Hospital
collaborator OTHER -
Xiangyang No.1 People's Hospital
collaborator OTHER -
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
XueFeng Yu, Doctor · Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2026-10-30
- Completion
- 2026-12-30
Countries
- China
Study Locations
More Related Trials
-
A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)
NCT02532855 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
NCT01076088 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
NCT02284893 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
NCT06613750 ·Status: COMPLETED ·Phase: PHASE4
-
Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function
NCT02304081 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus
NCT04014192 ·Status: UNKNOWN ·Phase: PHASE4
-
Using of SGLt2 Inhibitors in Patients With Type 2 DM
NCT06268977 ·Status: NOT_YET_RECRUITING
-
Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
NCT02104804 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
NCT01169090 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
NCT03169959 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
NCT04149067 ·Status: COMPLETED
-
Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors
NCT07108985 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
NCT02471404 ·Status: COMPLETED ·Phase: PHASE4
-
Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM
NCT00820573 ·Status: COMPLETED ·Phase: PHASE4
-
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
NCT03982381 ·Status: COMPLETED ·Phase: PHASE4
-
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
NCT02551874 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
NCT01590797 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients
NCT04445714 ·Status: COMPLETED ·Phase: PHASE4
-
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
NCT00103857 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
NCT02273050 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
NCT00842556 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.
NCT03714594 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
NCT01590771 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
NCT01709305 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology
NCT02401880 ·Status: COMPLETED ·Phase: PHASE4