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

Bayer

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus

Treatments

Drug: Placebo

Drug: Acarbose (Glucobay, BAYG5421)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01010100

PREDIAP

10139 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

204 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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