Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
NCT ID: NCT01010100
Last Updated: 2010-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2000-08-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Acarbose (Glucobay, BAYG5421)
50 mg TID
Arm 2
Placebo
50 mg TID
Interventions
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Acarbose (Glucobay, BAYG5421)
50 mg TID
Placebo
50 mg TID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Agost, Alicante, Spain
Alicante, Alicante, Spain
Crevillent, Alicante, Spain
Novelda, Alicante, Spain
San Vicent del Raspeig, Alicante, Spain
Terrassa, Barcelona, Spain
Trobajo del Camino, León, Spain
Begonte, Lugo, Spain
Villalba, Lugo, Spain
Madrid, Madrid, Spain
Camas, Sevilla, Spain
Constantí, Tarragona, Spain
Cornudella, Tarragona, Spain
el Morell, Tarragona, Spain
Falset, Tarragona, Spain
les Borges del Camp, Tarragona, Spain
Reus, Tarragona, Spain
Reus, Tarragona, Spain
Reus, Tarragona, Spain
Tarragona, Tarragona, Spain
Tarragona, Tarragona, Spain
Tortosa, Tarragona, Spain
Vinebre, Tarragona, Spain
Countries
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Other Identifiers
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PREDIAP
Identifier Type: -
Identifier Source: secondary_id
10139
Identifier Type: -
Identifier Source: org_study_id