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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01010100
First received: October 26, 2009
Last updated: December 23, 2010
Last verified: December 2010
History of Changes

October 26, 2009
December 23, 2010
August 2000
May 2007   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010100 on ClinicalTrials.gov Archive Site
  • Regression to the normality (NO impaired glucose homeostasis) [ Time Frame: Proportion of subjects that had regressed to normality after three years of treatment. ] [ Designated as safety issue: No ]
  • Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia) [ Time Frame: Three years and three months. ] [ Designated as safety issue: Yes ]
  • Evolution of blood pressure [ Time Frame: Three years and three months. ] [ Designated as safety issue: Yes ]
  • Evolution of lipid profile [ Time Frame: Three years and three months. ] [ Designated as safety issue: Yes ]
  • Evolution of anthropometric measurements [ Time Frame: Three years and three months. (BMI) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Delay in the conversion to diabetes mellitus [ Time Frame: Time until the confirmation of the diagnosis of Diabetes Mellitus ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Acarbose (Glucobay, BAYG5421)
    50 mg TID
  • Drug: Placebo
    50 mg TID
  • Experimental: Arm 1
    Intervention: Drug: Acarbose (Glucobay, BAYG5421)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01010100
10139, PREDIAP
No
Therapeutic Area Head, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP