Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the efficacy of pioglitazone taken with metformin
      on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.
    

Detailed description: 
      Diabetes is none of the most common, chronic diseases worldwide and affects nearly 200
      million people. It is the fourth or fifth leading cause of death in developed countries, and
      it is expected that diabetes will reach epidemic proportions, affecting 333 million people
      globally by 2025.

      The metabolic syndrome is a cluster of the most dangerous cardiovascular risk factors and
      includes diabetes and pre-diabetes in addition to abdominal obesity, low high-density
      lipoprotein cholesterol, high triglycerides and hypertension. It is estimated that around a
      quarter of the world's adult population has metabolic syndrome, and are twice as likely to
      die and three times as likely to have a heart attack or stroke when compared to people
      without the syndrome. In addition, non-diabetic people with metabolic syndrome have a
      fivefold greater risk of developing type 2 diabetes. The clustering of cardiovascular risk
      factors that typifies the metabolic syndrome is now considered the driving force for a
      cardiovascular disease epidemic.

      Metabolic syndrome has been recently defined by a Consensus Conference of the International
      Diabetes Federation as a cluster of clinical and laboratory signs characterized by the
      presence of abnormal deposition of fat tissue in the abdomen and visceral districts, and at
      least two other clinical and laboratory abnormalities, including altered glucose metabolism
      or type 2 diabetes and decreased levels of high-density lipoprotein cholesterol. One of the
      underlying pathophysiological mechanisms of metabolic syndrome is insulin resistance,
      characterized by an increased glucose output from the liver, and reduced glucose uptake in
      the muscle and adipose tissue cells. Drugs whose mechanism of action consists of increasing
      insulin sensitivity in the target tissues are able to reduce the clinical manifestations and
      consequences of metabolic syndrome.

      While each individual component of metabolic syndrome confers an increased risk of
      cardiovascular-related complications or death, this risk is more pronounced when the syndrome
      itself is present. The more components of metabolic syndrome are evident, the higher is the
      cardiovascular mortality rate.
    

Intervention name(s): Pioglitazone and Metformin; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 15 mg, tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone 15 mg, tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.; Pioglitazone placebo-matching tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone placebo-matching tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.
Other intervention name(s): ACTOS®; AD4833
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy