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Last Updated: June 17, 2024

CLINICAL TRIALS PROFILE FOR JARDIANCE


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505(b)(2) Clinical Trials for JARDIANCE

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 Dosage NCT06083675 ↗ Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes Withdrawn Novo Nordisk A/S Phase 3 2024-01-26 This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for JARDIANCE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01001962 ↗ Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics Unknown status Aristotle University Of Thessaloniki Phase 4 2016-01-01 Objectives: Primary 1. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
NCT02367131 ↗ Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus Completed Eli Lilly and Company 2015-02-24 Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02367131 ↗ Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus Completed Boehringer Ingelheim 2015-02-24 Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02401880 ↗ Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology Completed Profil Institut für Stoffwechselforschung GmbH Phase 4 2015-05-01 The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
NCT02471963 ↗ Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function Completed University of Erlangen-Nürnberg Medical School Phase 3 2014-12-01 Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and obesity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for JARDIANCE

Condition Name

Condition Name for JARDIANCE
Intervention Trials
Diabetes Mellitus, Type 2 10
Type 2 Diabetes 6
Type 2 Diabetes Mellitus 6
Type2 Diabetes 5
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Condition MeSH

Condition MeSH for JARDIANCE
Intervention Trials
Diabetes Mellitus 32
Diabetes Mellitus, Type 2 31
Kidney Diseases 8
Heart Failure 7
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Clinical Trial Locations for JARDIANCE

Trials by Country

Trials by Country for JARDIANCE
Location Trials
United States 22
India 15
Poland 10
Germany 8
Austria 8
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Trials by US State

Trials by US State for JARDIANCE
Location Trials
Texas 4
New York 3
Ohio 2
Minnesota 2
Tennessee 1
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Clinical Trial Progress for JARDIANCE

Clinical Trial Phase

Clinical Trial Phase for JARDIANCE
Clinical Trial Phase Trials
Phase 4 26
Phase 3 13
Phase 2/Phase 3 4
[disabled in preview] 13
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Clinical Trial Status

Clinical Trial Status for JARDIANCE
Clinical Trial Phase Trials
Completed 27
Not yet recruiting 15
Recruiting 12
[disabled in preview] 11
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Clinical Trial Sponsors for JARDIANCE

Sponsor Name

Sponsor Name for JARDIANCE
Sponsor Trials
Boehringer Ingelheim 16
Eli Lilly and Company 4
University Hospital, Basel, Switzerland 3
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Sponsor Type

Sponsor Type for JARDIANCE
Sponsor Trials
Other 114
Industry 29
NIH 3
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