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Clinical Trial Details

Trial ID: L5714
Source ID: NCT01010100
Associated Drug: Acarbose (Glucobay, Bayg5421)
Title: Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Acarbose (Glucobay, BAYG5421)|DRUG: Placebo
Outcome Measures: Primary: The principal objective was to determine if the administration of small doses of Acarbose could prevent or delay the appearance of Type 2 DM in a population of subjects with impaired glucose homeostasis., The main criterion for the evaluation of the primary objective was the proportion of diabetic subjects after three years of treatment and another time after three months of wash-out with placebo. | Secondary: Regression to the normality (NO impaired glucose homeostasis), Proportion of subjects that had regressed to normality after three years of treatment.|Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia), Three years and three months.|Evolution of blood pressure, Three years and three months.|Evolution of lipid profile, Three years and three months.|Evolution of anthropometric measurements, Three years and three months. (BMI)|The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure, Time until the appearance or progression of cardiovascular episodes|Delay in the conversion to diabetes mellitus, Time until the confirmation of the diagnosis of Diabetes Mellitus
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 204
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2000-08
Completion Date: 2007-05
Results First Posted:
Last Update Posted: 2010-12-28
Locations: Agost, Alicante, 03698, Spain|Crevillente, Alicante, Spain|Novelda, Alicante, 03660, Spain|San Vicente del Raspeig, Alicante, 03690, Spain|Terrassa, Barcelona, 08223, Spain|Trobajo del Camino, León, 24010, Spain|Begonte, Lugo, 27373, Spain|Villalba, Lugo, 27800, Spain|Camas, Sevilla, 41900, Spain|Constanti, Tarragona, 43120, Spain|Cornudella, Tarragona, 43360, Spain|El Morell, Tarragona, 43760, Spain|Falset, Tarragona, 43730, Spain|Les Borges del Camp, Tarragona, 43350, Spain|Reus, Tarragona, 43201, Spain|Reus, Tarragona, 43202, Spain|Reus, Tarragona, 43203, Spain|Tortosa, Tarragona, 43500, Spain|Vinebre, Tarragona, 43729, Spain|Alicante, 03007, Spain|Madrid, 28033, Spain|Tarragona, 43005, Spain|Tarragona, 43006, Spain
URL: https://clinicaltrials.gov/show/NCT01010100

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress