check_circleStudy Completed
Diabetes Mellitus
Bayer Identifier:
10139
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Prevent/delay development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care
Trial purpose
The purpose of the study is to determine if the administration of small doses of Acarbose can prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with prediabetes.
Key Participants Requirements
Sex
BothAge
40 - 75 YearsTrial summary
Enrollment Goal
204Trial Dates
August 2000 - May 2007Phase
Phase 3Could I Receive a placebo
YesProducts
Acarbose (Precose/Glucobay, BAYG5421)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 1 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 4 | Reus, 43203, Spain |
Completed | Area Bàsica de Salud Borges del Camp | Les Borges del Camp, 43350, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Cornudella | Cornudella, 43360, Spain |
Completed | Area Bàsica de Salud Constantí | Constanti, 43120, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Centre d'Atenció Primària El Temple | Tortosa, 43500, Spain |
Completed | Centro de Salud Novelda (Area 17) | Novelda, 03660, Spain |
Completed | Centro de Salud de Crevillente (Area 19) | Crevillente, Spain |
Completed | Centro de Salud Begonte | Begonte, 27373, Spain |
Completed | Centro de Salud Mar Báltico | Madrid, 28033, Spain |
Completed | Area Bàsica de Salud Reus 2 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 1 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 1 | Reus, 43202, Spain |
Completed | Area Bàsica de Salud Reus 3 - CAP Sant Pere | Reus, 43201, Spain |
Completed | Area Basica de Salud Vinebre | Vinebre, 43729, Spain |
Completed | Area Bàsica de Salud Falset | Falset, 43730, Spain |
Completed | Area Bàsica de Salud Torreforta - La Granja | Tarragona, 43006, Spain |
Completed | Area Bàsica de Salud El Morell | El Morell, 43760, Spain |
Completed | Centre d'Atenció Primària Jaume I | Tarragona, 43005, Spain |
Completed | Centro de Salud Agost (Area 18) | Agost, 03698, Spain |
Completed | Centro de Salud La Florida | Alicante, 03007, Spain |
Completed | Centro de Salud San Vicente de Raspeig (Area 18) | San Vicente del Raspeig, 03690, Spain |
Completed | Centro de Salud Villalba | Villalba, 27800, Spain |
Completed | Centro de saluld de camas | Camas, 41900, Spain |
Completed | Centro de Salud Trobajo del Camino | Trobajo del Camino, 24010, Spain |
Completed | CAP Terrassa Sud | Terrassa, 08223, Spain |
Primary Outcome
- 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.date_rangeTime Frame: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.enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Regression to the normality (NO impaired glucose homeostasis)date_rangeTime Frame:Proportion of subjects that had regressed to normality after three years of treatment.enhanced_encryptionnoSafety Issue:
- Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)date_rangeTime Frame:Three years and three months.enhanced_encryptionyesSafety Issue:
- Evolution of blood pressuredate_rangeTime Frame:Three years and three months.enhanced_encryptionyesSafety Issue:
- Evolution of lipid profiledate_rangeTime Frame:Three years and three months.enhanced_encryptionyesSafety Issue:
- Evolution of anthropometric measurementsdate_rangeTime Frame:Three years and three months. (BMI)enhanced_encryptionyesSafety Issue:
- The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation proceduredate_rangeTime Frame:Time until the appearance or progression of cardiovascular episodesenhanced_encryptionyesSafety Issue:
- Delay in the conversion to diabetes mellitusdate_rangeTime Frame:Time until the confirmation of the diagnosis of Diabetes Mellitusenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2