check_circleStudy Completed

Diabetes Mellitus

Bayer Identifier:

10139

ClinicalTrials.gov Identifier:

NCT01010100

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

Both

Age

40 - 75 Years

  • - 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
  • - 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
August 2000 - May 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 1Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 4Reus, 43203, Spain
Completed
Area Bàsica de Salud Borges del CampLes Borges del Camp, 43350, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud CornudellaCornudella, 43360, Spain
Completed
Area Bàsica de Salud ConstantíConstanti, 43120, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Centre d'Atenció Primària El TempleTortosa, 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 BegonteBegonte, 27373, Spain
Completed
Centro de Salud Mar BálticoMadrid, 28033, Spain
Completed
Area Bàsica de Salud Reus 2Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 1Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 1Reus, 43202, Spain
Completed
Area Bàsica de Salud Reus 3 - CAP Sant PereReus, 43201, Spain
Completed
Area Basica de Salud VinebreVinebre, 43729, Spain
Completed
Area Bàsica de Salud FalsetFalset, 43730, Spain
Completed
Area Bàsica de Salud Torreforta - La GranjaTarragona, 43006, Spain
Completed
Area Bàsica de Salud El MorellEl Morell, 43760, Spain
Completed
Centre d'Atenció Primària Jaume ITarragona, 43005, Spain
Completed
Centro de Salud Agost (Area 18)Agost, 03698, Spain
Completed
Centro de Salud La FloridaAlicante, 03007, Spain
Completed
Centro de Salud San Vicente de Raspeig (Area 18)San Vicente del Raspeig, 03690, Spain
Completed
Centro de Salud VillalbaVillalba, 27800, Spain
Completed
Centro de saluld de camasCamas, 41900, Spain
Completed
Centro de Salud Trobajo del CaminoTrobajo del Camino, 24010, Spain
Completed
CAP Terrassa SudTerrassa, 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_encryption
    Safety Issue:
    no

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_encryption
    Safety Issue:
    no
  • 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.
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    Safety Issue:
    yes
  • Evolution of blood pressure
    date_rangeTime Frame:
    Three years and three months.
    enhanced_encryption
    Safety Issue:
    yes
  • Evolution of lipid profile
    date_rangeTime Frame:
    Three years and three months.
    enhanced_encryption
    Safety Issue:
    yes
  • Evolution of anthropometric measurements
    date_rangeTime Frame:
    Three years and three months. (BMI)
    enhanced_encryption
    Safety Issue:
    yes
  • The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure
    date_rangeTime Frame:
    Time until the appearance or progression of cardiovascular episodes
    enhanced_encryption
    Safety Issue:
    yes
  • Delay in the conversion to diabetes mellitus
    date_rangeTime Frame:
    Time until the confirmation of the diagnosis of Diabetes Mellitus
    enhanced_encryption
    Safety Issue:
    no

Trial design

A multi-centre, parallel, double-blind, randomised and placebo controlled Spanish study, to prevent or delay the development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care (PREDIAP)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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