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Completed

NCT Number: NCT01010100

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agost, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose (Glucobay, BAYG5421)

Drug

50 mg TID

Placebo

Drug

50 mg TID

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Nov 9, 2009
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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