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Last Updated: July 23, 2024

CLINICAL TRIALS PROFILE FOR EMPAGLIFLOZIN


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505(b)(2) Clinical Trials for Empagliflozin

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↗ Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes Withdrawn Novo Nordisk A/S Phase 3 2024-01-26 This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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 Empagliflozin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00881530 ↗ Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension Completed Boehringer Ingelheim Phase 2 2009-03-01 The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
NCT00885118 ↗ 4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM) Completed Boehringer Ingelheim Phase 2 2009-04-01 The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
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
NCT01111318 ↗ Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function Completed Boehringer Ingelheim Phase 1 2010-07-01 The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
NCT01111331 ↗ Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers Completed Boehringer Ingelheim Phase 1 2010-05-01 The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.
NCT01131676 ↗ BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). Completed Eli Lilly and Company Phase 3 2010-07-01 The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
NCT01131676 ↗ BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). Completed Boehringer Ingelheim Phase 3 2010-07-01 The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Empagliflozin

Condition Name

Condition Name for Empagliflozin
Intervention Trials
Diabetes Mellitus, Type 2 62
Healthy 31
Heart Failure 26
Type 2 Diabetes 23
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Condition MeSH

Condition MeSH for Empagliflozin
Intervention Trials
Diabetes Mellitus 137
Diabetes Mellitus, Type 2 129
Heart Failure 47
Kidney Diseases 27
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Clinical Trial Locations for Empagliflozin

Trials by Country

Trials by Country for Empagliflozin
Location Trials
United States 732
Canada 147
Germany 64
Japan 51
Australia 36
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Trials by US State

Trials by US State for Empagliflozin
Location Trials
Texas 45
Florida 35
California 34
New York 31
Ohio 29
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Clinical Trial Progress for Empagliflozin

Clinical Trial Phase

Clinical Trial Phase for Empagliflozin
Clinical Trial Phase Trials
Phase 4 93
Phase 3 75
Phase 2/Phase 3 14
[disabled in preview] 140
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Clinical Trial Status

Clinical Trial Status for Empagliflozin
Clinical Trial Phase Trials
Completed 135
Recruiting 76
Not yet recruiting 70
[disabled in preview] 42
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Clinical Trial Sponsors for Empagliflozin

Sponsor Name

Sponsor Name for Empagliflozin
Sponsor Trials
Boehringer Ingelheim 105
Eli Lilly and Company 51
University Hospital, Basel, Switzerland 7
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Sponsor Type

Sponsor Type for Empagliflozin
Sponsor Trials
Other 357
Industry 202
NIH 10
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