Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Anti-Infective Agents

Empagliflozin

Sodium-Glucose Transporter 2 Inhibitors

Dipeptidyl-Peptidase IV Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

empagliflozin

DPP-4 inhibitors

SGLT-2 inhibitors

Pasi Korhonen, 358-50-3652990

The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor and to patients initiating other Sodium glucose co-transporter-2 (SGLT-2) inhibitors (i.e. two comparator groups)

Empa PASS on Urinary Tract Malignancies

Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

non-renal, non- urinary bladder, urinary tract cancers

Eli Lilly and Company

Boehringer Ingelheim

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Metformin

Each participant will receive empagliflozin 25mg daily for 3 months

Each participant will receive metformin 1500mg daily for 3 months

Each participant will receive empagliflozin 25mg daily for 3 months.

Each participant will receive metformin 1500mg daily for 3 months.

Thozhukat Sathyapalan, MBBS FRCP MD

This a randomised open-label parallel study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg daily for three months. The aim of the study is to examine the effect of empagliflozin on hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.

Polycystic ovary syndrome (PCOS) is a very common condition in women that may present with irregular periods, excessive hair growth on the face and body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease.

In this study, a medication named Empagliflozin will be tested. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. SGLT-2 stands for sodium glucose co-transporter 2. Empagliflozin, in simple terms, helps in reducing high blood glucose levels by increasing the amount of glucose passed in your urine. This medicine is usually used in patients with type 2 diabetes and has led to improved blood pressure and weight loss in addition to improving blood glucose levels.

We want to give Empagliflozin to women with PCOS to see its effect on hormones related to PCOS and the risk factors for diabetes and heart disease. We will be comparing its effects to metformin (another drug for diabetes) which has already been used in PCOS with very good results.

Empagliflozin vs Metformin in PCOS

The Effect of Empagliflozin Versus Metformin on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Randomised Open-label Parallel Study.

Endothelial function as measured by RHI (reactive hyperaemia index) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Inflammatory markers (hsCRP) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Insulin resistance as measured by HOMA (fasting glucose \& insulin) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Body weight will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Blood pressure will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Lipid profile will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Hormonal parameters including free androgen index will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Endothelial function measured by microparticles will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Quality of life will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Hull University Teaching Hospitals NHS Trust

Linagliptin

Incretins

Hormones

Hormone Antagonists

Patients will receive Metformin (1500 mg orally/day) for 12 weeks .

Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.

Patients will receive Linagliptin (10 mg orally/day) for 12 weeks

This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)

Empagliflozin 25 mg

Linagliptin 10 mg

Metformin 1500 mg

Haidy M Sami, Master

Noha A Hamdy, PhD

Ahmed I ElMallah, PhD

Hanan N Abdel Hafez, PhD

Haidi M Sami, Master

The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Patients with polycystic ovary syndrome will be randomized to three arms:

* Metformin (standard care)
* Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested

This study is for the treatment of polycystic ovary syndrome (PCOS)

Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women

total testosterone \& sex hormone binding globulin (SHBG)

Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II

Alexandria University

Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Empagliflozin 10 MG

Placebo

Anna Borowiec, Ph D

Barbara Nasilowska

Anna Borowiec, PhD

EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. The study will be carried out in accordance with GCP and monitoring will be outsourced to a subcontractor - CRO. The examination will be insured and will begin as soon as the required approvals are obtained.

Malignant neoplasms are the second most common cause of death in Poland. Cancer mortality decreased by 27% over the past 25 years. Improved survival in cancer patients is related to several factors, such as prevention, early detection and the introduction of new chemotherapy regimens. However, the benefits of administration of anti-cancer drugs are partially limited by their adverse effects on the cardiovascular system, resulting in increased morbidity and mortality from complications of this treatment. The most serious toxic effect of chemotherapy is damage to the heart muscle leading to its failure, often referred to as 'cardiotoxicity'. This serious complication remains an unresolved clinical problem. The use of doxorubicin is associated with the development of congestive heart failure even in 48% of patients at the doxorubicin total dose of 700 mg/m2. The only drug approved for the prophylactic treatment of cardiac complications is dexrazoxane. However, it is only recommended for patients with advanced breast cancer receiving doxorubicin or epirubicin who have previously received a cumulative dose of 300 mg/m2 of doxorubicin or a cumulative epirubicin dose of 540 mg/m2, when further anthracycline therapy is required. Dexrazoxane is an expensive drug and may influence the effectiveness of chemotherapy. Routine prophylaxis of myocardial dysfunction is not currently recommended due to insufficient data from randomized clinical trials. So far, the prophylactic effects of such cardiological drugs as: angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), beta-blockers, statins and ranolazine have been studied. The results of these studies are contradictory. Therefore, at present, only symptomatic patients with decreased left ventricular ejection fraction or elevated levels of cardiac biomarkers are eligible for treatment with heart failure medications. Empagliflozin is an orally administered once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor proven to treat patients with chronic heart failure of different aetiologies, also with preserved left ventricle systolic function. This drug also has additional nephroprotective, anti-inflammatory and metabolic effects. In recent animal studies, the cardioprotective effect of empagliflozin during the use of anthracyclines was demonstrated.

EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. This is the first study of this type in the world, we hope that the results of this project will change the standards of management of oncological patients and contribute to the improvement of their survival and quality of life.

Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines

Evaluation of the Effectiveness of Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines (EMPACT Study).

echocardiography, cardiovascular magnetic resonance

Kansas City Cardiomyopathy Questionnaire, the minimum and maximum values:0-100, higher scores mean a better outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Empa PASS on Urinary Tract Malignancies	NCT03464045	Diabetes Mellit...	empagliflozin DPP-4 inhibitor... SGLT-2 inhibito...	18 Years -	Boehringer Ingelheim
Empagliflozin vs Metformin in PCOS	NCT03008551	Polycystic Ovar...	Empagliflozin Metformin	18 Years - 45 Years	Hull University Teaching Hospitals NHS Trust
Empagliflozin vs Metformin in PCOS	NCT03008551	Polycystic Ovar...	Empagliflozin Metformin	18 Years - 45 Years	Hull University Teaching Hospitals NHS Trust
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome	NCT05200793	Polycystic Ovar...	Empagliflozin 2... Linagliptin 10 ... Metformin 1500 ...	18 Years - 40 Years	Alexandria University
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines	NCT05271162	Cardiotoxicity	Empagliflozin 1... Placebo	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for empagliflozin