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A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

The purpose of this study is: * To test the safety of the research study drug MK-3102.* To assess how well the research study drug MK-3102 lowers blood sugar levels (fasting plasma glucose [FPG], post meal glucose [PMG], and glycosylated hemoglobin…

Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early diabetes

1. To assess whether linagliptin compared with placebo improves arterial stiffness in treatment naïve subjects with type 2 diabetes.2. To assess whether linagliptin compared with placebo improves blood pressure parameters, inflammatory and…

A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in patients with T2DM

Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…

A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…

A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia

Primary objective of this trial is to generate open-label, long-term (up to 12 months) safety and tolerability data for ZS in subjects with hyperkalaemia (S-K * 5.1 mmol/L)Secondary objectives:* To evaluate the portion of ZS-treated subjects in whom…

A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

Primary Objective:To determine the effect of the Topical Gentamicin-Collagen Sponge (gentamicin-sponge) in combination with systemic antibiotic therapy compared to placebo-sponge and no-sponge, both in combination with systemic antibiotic therapy on…

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus * Study two

Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:•LDL-C levels at Day 510•Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levels. The secondary objectives of this study…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:*LDL-C levels at Day 510*Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levelsThe secondary objectives of this study are…

A randomized, double-blind, placebo controlled, crossover study to determine the effect of 5g egg protein hydrolysate (NWT-03) on arterial stiffness, microcirculation and blood pressure in otherwise healthy subjects with Metabolic Syndrome

To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral…

A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis.

The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…

REducing with MetfOrmin Vascular
Adverse Lesions in Type 1 diabetes mellitus

Primary objective: To test for the first time in a double-blind randomized, placebo controlled trial whether three years treatment with metformin 1000 mg bd added to titrated insulin therapy (towards target HbA1c 7.0%/ 53 mmol/mol) reduces…

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemia

Primary Objective(s):To evaluate the efficacy of ISIS 304801 as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.Secondary Objectives:To evaluate the efficacy of ISIS 304801 as compared to placebo on the…

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of empagliflozin as adjunctive to insulin therapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3)

The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 2,5mg, 10mg and 25mg in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy.…

PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBOCONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615) , IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS - SPIRE 2

The primary objective of this clinical trial is to demonstrate the superior efficacy of bococizumab compared with placebo in reducing the risk of major CV events, a composite endpoint which includes adjudicated and confirmed CV death, non fatal MI (…

Using D-Galactose as a food supplement in Congenital Disorders of Glycosylation (CDG)

The goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital Disorders of Glycosylation.