Trial Condition(s):

Diabetes Mellitus

Prevent/delay development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care

Bayer Identifier:

10139

ClinicalTrials.gov Identifier:

NCT01010100

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- Age > 40 and < 75 years old
 - Men and women
 - Able to give voluntary informed consent
 - Existence of one or more of the following risk factors:
 - Body Mass Index (BMI) > 27 mg/Kg2
 - One or more family members with diabetes determined by anamnesis.
 - Personal antecedents of previous blood glucose anomalies (gestational diabetes reverted after the lactation time, before-during surgical stress, fasting glycaemia > 110 mg/dL (6,1 mM) and < 126 mg/dL (7 mM) registered in the Clinical History during the last 3 years,  etc.)
 - Previous consumption of drugs with hyperglycaemic capacity for a period of 3 months continuously or more than 6 months discontinuously
Exclusion Criteria
- Type 2 DM
 - Pregnancy during the study
 - Nursing women
 - Major debilitating (e.g. collagen vascular diseases, failure of major organ, psychosis, severe infections, neutropenia, BMI < 20 mg/Kg2)
 - Subjects taking a prohibited drug (see protocol)
 - Subjects taking drugs that can impair intestinal motility and/or carbohydrate absorption (i.e. cholestyramine, neomycin)
 - Recent cardiovascular events (within last 6 months) such as myocardial infarction, cerebrovascular accident, congestive heart failure
 - Serum creatinine > 2 mg/Dl
 - Fasting triglycerides > 10 mm/L (> 885 mg/dL)
 - AST elevation > 2.5 times above the upper limit of normal
 - Subjects with hyper/hypothyroidism non compensated
 - Subjects with documented gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesia, malabsorption syndrome, chronic diarrhoea states, enteropathies, inflammatory bowel diseases, partial intestinal obstruction, large hernias)
 - Subjects with any emotional disorder or substance abuse (e.g. severe depression, alcohol or drug abuse)
 - Hypersensitivity to Acarbose

Trial Summary

Enrollment Goal
204
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Area Bàsica de Salud Reus 2

Reus, Spain, 43202

Status
Completed
 
Locations

Area Bàsica de Salud Reus 1

Reus, Spain, 43202

Status
Completed
 
Locations

Area Bàsica de Salud Reus 4

Reus, Spain, 43203

Status
Completed
 
Locations

Area Bàsica de Salud Borges del Camp

Les Borges del Camp, Spain, 43350

Status
Completed
 
Locations

Area Bàsica de Salud Cornudella

Cornudella, Spain, 43360

Status
Completed
 
Locations

Area Bàsica de Salud Constantí

Constanti, Spain, 43120

Status
Completed
 
Locations

Centre d'Atenció Primària El Temple

Tortosa, Spain, 43500

Status
Completed
 
Locations

Centro de Salud Novelda (Area 17)

Novelda, Spain, 03660

Status
Completed
 
Locations

Centro de Salud de Crevillente (Area 19)

Crevillente, Spain

Status
Completed
 
Locations

Centro de Salud Begonte

Begonte, Spain, 27373

Status
Completed
 
Locations

Centro de Salud Mar Báltico

Madrid, Spain, 28033

Status
Completed
 
Locations

Area Bàsica de Salud Reus 3 - CAP Sant Pere

Reus, Spain, 43201

Status
Completed
 
Locations

Area Basica de Salud Vinebre

Vinebre, Spain, 43729

Status
Completed
 
Locations

Area Bàsica de Salud Falset

Falset, Spain, 43730

Status
Completed
 
Locations

Area Bàsica de Salud Torreforta - La Granja

Tarragona, Spain, 43006

Status
Completed
 
Locations

Area Bàsica de Salud El Morell

El Morell, Spain, 43760

Status
Completed
 
Locations

Centre d'Atenció Primària Jaume I

Tarragona, Spain, 43005

Status
Completed
 
Locations

Centro de Salud Agost (Area 18)

Agost, Spain, 03698

Status
Completed
 
Locations

Centro de Salud La Florida

Alicante, Spain, 03007

Status
Completed
 
Locations

Centro de Salud San Vicente de Raspeig (Area 18)

San Vicente del Raspeig, Spain, 03690

Status
Completed
 
Locations

Centro de Salud Villalba

Villalba, Spain, 27800

Status
Completed
 
Locations

Centro de saluld de camas

Camas, Spain, 41900

Status
Completed
 
Locations

Centro de Salud Trobajo del Camino

Trobajo del Camino, Spain, 24010

Status
Completed
 
Locations

CAP Terrassa Sud

Terrassa, Spain, 08223

Status
Completed
 

Trial Design