Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010100
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : December 28, 2010
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Acarbose (Glucobay, BAYG5421) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2000
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
Experimental: Arm 1 Drug: Acarbose (Glucobay, BAYG5421)
50 mg TID

Placebo Comparator: Arm 2 Drug: Placebo
50 mg TID

Primary Outcome Measures :
  1. 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. [ Time 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. ]

Secondary Outcome Measures :
  1. Regression to the normality (NO impaired glucose homeostasis) [ Time Frame: Proportion of subjects that had regressed to normality after three years of treatment. ]
  2. Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia) [ Time Frame: Three years and three months. ]
  3. Evolution of blood pressure [ Time Frame: Three years and three months. ]
  4. Evolution of lipid profile [ Time Frame: Three years and three months. ]
  5. Evolution of anthropometric measurements [ Time Frame: Three years and three months. (BMI) ]
  6. The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure [ Time Frame: Time until the appearance or progression of cardiovascular episodes ]
  7. Delay in the conversion to diabetes mellitus [ Time Frame: Time until the confirmation of the diagnosis of Diabetes Mellitus ]

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010100

Agost, Alicante, Spain, 03698
Crevillente, Alicante, Spain
Novelda, Alicante, Spain, 03660
San Vicente del Raspeig, Alicante, Spain, 03690
Terrassa, Barcelona, Spain, 08223
Trobajo del Camino, León, Spain, 24010
Begonte, Lugo, Spain, 27373
Villalba, Lugo, Spain, 27800
Camas, Sevilla, Spain, 41900
Constanti, Tarragona, Spain, 43120
Cornudella, Tarragona, Spain, 43360
El Morell, Tarragona, Spain, 43760
Falset, Tarragona, Spain, 43730
Les Borges del Camp, Tarragona, Spain, 43350
Reus, Tarragona, Spain, 43201
Reus, Tarragona, Spain, 43202
Reus, Tarragona, Spain, 43203
Tortosa, Tarragona, Spain, 43500
Vinebre, Tarragona, Spain, 43729
Alicante, Spain, 03007
Madrid, Spain, 28033
Tarragona, Spain, 43005
Tarragona, Spain, 43006
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT01010100     History of Changes
Other Study ID Numbers: 10139
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: December 2010

Keywords provided by Bayer:
Metabolic Disease
IGT Impaired Glucose Tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs