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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Acarbose (Glucobay, BAYG5421)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acarbose (Glucobay, BAYG5421)<br>* 50 mg TID<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 50 mg TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Disease, IGT Impaired Glucose Tolerance