The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. Dapagliflozin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 40 countries worldwide including the USA and Europe. Saxagliptin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 90 countries worldwide. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they haven't been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from the food that is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening phase of up to 6 months if Investigator thinks that some of the screening tests can be repeated, followed by a 2 week lead in phase. Thereafter there will be a 26W short-term treatment phase (W1-26), and a 26 W long-term treatment phase (W27-52). Following this there will be a follow-up telephone call on week 56 and a post study visit at W104. At day 1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, and until the end of the study, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose.Starting at W32 or W40, i.e., after the end of the primary endpoints, patients with background medication of metformin only, and an HbA1c value < 7.5% at W26 or W32, will undergo a third randomization. Eligible subjects from the treatment arms will undergo the randomized withdrawal of background medication, while eligible patients from the placebo arm will undergo, in addition to randomized withdrawal of background medication a randomized switch to active treatment. Short- and long-term period study visits can be delayed by a maximum of 11 months in total. If the duration of investigational product administration is longer than 52 (+1) weeks, the safety follow-up period should be shortened such that the complete study duration does not exceed 104 weeks. The W104 visit should not be delayed.If more than 12 weeks elapse between the HbA1c collection at W26 and the third rand at W32, or the HbA1c collection at W32 and the third rand at W40, the subject should not go through this rand as the HbA1c value would no longer be reliable to ascertain eligibility for the third rand

NCT03199053

Conditions

1. Diabetes Mellitus, Type 2

Interventions

1. Drug: Dapagliflozin
2. Drug: Saxagliptin
3. Drug: Placebo

MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2

HPO:Diabetes mellitus Type II diabetes mellitus

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

NCT04170543

Conditions

1. Diabetic Kidney Disease

Interventions

1. Drug: MEDI3506
2. Drug: Placebo
3. Drug: Dapagliflozin

MeSH:Kidney Diseases Diabetic Nephropathies

HPO:Abnormality of the kidney Nephropathy

TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID-19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. This study will assess the efficacy of a novel immunomodulatory agent and a novel combination of approved agents which may protect the patient against end-organ damage and modulate the pulmonary vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel combination of the approved agents dapagliflozin and ambrisentan against Standard of Care.

NCT04393246

Conditions

1. COVID-19

Interventions

1. Drug: EDP1815
2. Drug: Dapagliflozin
3. Drug: Ambrisentan
4. Other: Standard of care

The purpose of the study is to evaluate the efficacy and safety of AZD9977 alone and AZD9977 in combination with dapagliflozin and to assess the dose-response relationship of placebo, AZD9977 alone, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 55%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between 20 and 60 mL/min, with at least 30% of participants with eGFR <30 mL/min and a maximum of 25% of participants with eGFR >45 mL/min]), including at least 40% of participants with type 2 diabetes mellitus (T2DM).

NCT04595370

Conditions

1. Heart Failure
2. Chronic Kidney Disease

Interventions

1. Drug: AZD9977
2. Drug: Dapagliflozin
3. Drug: Placebo

MeSH:Kidney Diseases Renal Insufficiency, Chronic Heart Failure

HPO:Abnormal left ventricular function Abnormality of the kidney Chronic kidney disease Congestive heart failure Nephropathy Right ventricular failure