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Last Updated: May 19, 2024

CLINICAL TRIALS PROFILE FOR CANAGLIFLOZIN


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505(b)(2) Clinical Trials for CANAGLIFLOZIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting College of Pharmaceutical Sciences at Zhejiang University N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting Zhang Xiaofeng,MD N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CANAGLIFLOZIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00642278 ↗ An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 2 2008-04-01 The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
NCT00650806 ↗ A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 2 2008-05-01 The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.
NCT00963768 ↗ A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 2007-06-01 The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.
NCT00968812 ↗ CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride Completed Janssen Research & Development, LLC Phase 3 2009-09-01 The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
NCT01032629 ↗ CANVAS - CANagliflozin cardioVascular Assessment Study Completed The George Institute for Global Health, Australia Phase 3 2009-12-09 The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CANAGLIFLOZIN

Condition Name

Condition Name for CANAGLIFLOZIN
Intervention Trials
Healthy 40
Diabetes Mellitus, Type 2 36
Type 2 Diabetes Mellitus 13
Type 2 Diabetes 7
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Condition MeSH

Condition MeSH for CANAGLIFLOZIN
Intervention Trials
Diabetes Mellitus, Type 2 61
Diabetes Mellitus 60
Kidney Diseases 9
Heart Failure 7
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Clinical Trial Locations for CANAGLIFLOZIN

Trials by Country

Trials by Country for CANAGLIFLOZIN
Location Trials
United States 609
Canada 62
India 22
Mexico 18
Germany 14
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Trials by US State

Trials by US State for CANAGLIFLOZIN
Location Trials
Florida 32
California 30
Texas 29
Arizona 26
Ohio 22
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Clinical Trial Progress for CANAGLIFLOZIN

Clinical Trial Phase

Clinical Trial Phase for CANAGLIFLOZIN
Clinical Trial Phase Trials
Phase 4 35
Phase 3 23
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for CANAGLIFLOZIN
Clinical Trial Phase Trials
Completed 94
Recruiting 16
Not yet recruiting 13
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Clinical Trial Sponsors for CANAGLIFLOZIN

Sponsor Name

Sponsor Name for CANAGLIFLOZIN
Sponsor Trials
Janssen Research & Development, LLC 41
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 31
Janssen Scientific Affairs, LLC 8
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Sponsor Type

Sponsor Type for CANAGLIFLOZIN
Sponsor Trials
Industry 103
Other 90
NIH 6
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