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The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in subjects with type 2 diabetes mellitus and acute coronary syndrome.
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Results from five phase 3 double-blind, placebo-controlled, 26-week studies have demonstrated that alogliptin is effective in reducing glycosylated hemoglobin as monotherapy and when added to commonly used antidiabetic agents, including sulfonylureas, metformin, thiazolidinediones, and insulin. Alogliptin is well-tolerated and associated with few adverse events.
Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus subjects who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.
This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in subjects with type 2 diabetes mellitus and acute coronary syndrome.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Takeda Global Research & Development Center, Inc.
Published on BioPortfolio: 2014-08-27T03:19:38-0400
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea a...
The purpose of this study is to determine the pharmacokinetic and safety profile of Alogliptin in children, adolescents and adults with Type 2 Diabetes Mellitus.
The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in subjects with type 2 diabetes mellitus who are inadequately controlled with die...
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
Metformin is recommended as the first-line treatment of type 2 diabetes mellitus. Despite its common use, few studies have been conducted to precisely measure the efficacy of metformin versus placebo ...
We investigated the effect of alogliptin and gliclazide on endothelial progenitor cells (EPCs) in type 2 diabetes.
Type 2 diabetes mellitus has been an established risk factor for cognitive decline, which is recently recognized as a new type of diabetes-related complication. Although wide-range of cognitive domain...
Weekly glucagon-like peptide-1 receptor agonist albiglutide as monotherapy improves glycemic parameters in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study.
This phase 3, randomized, double-blind 24-week study with extension to 1 year assessed efficacy and safety of albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus (T2DM...
To determine the effect of n-3 polyunsaturated fatty acids (n-3PUFAs) supplementation on circulatory resistin and monocyte chemoattractant 1 (MCP-1) levels in type 2 diabetes mellitus (T2DM) patients.
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...