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)

Bayer0 sites204 target enrollmentAugust 2000

ConditionsDiabetes Mellitus

InterventionsAcarbose (Glucobay, BAYG5421)Placebo

DrugsAcarbose (Glucobay, BAYG5421)Placebo

Overview

Phase: Phase 3
Intervention: Acarbose (Glucobay, BAYG5421)
Conditions: Diabetes Mellitus
Sponsor: Bayer
Enrollment: 204
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

May 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Eligibility Criteria

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

Arms & Interventions

Arm 1

Intervention: Acarbose (Glucobay, BAYG5421)

Arm 2

Intervention: Placebo

Outcomes

Primary Outcomes

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

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)
Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)(Three years and three months.)
Regression to the normality (NO impaired glucose homeostasis)(Proportion of subjects that had regressed to normality after three years of treatment.)
Evolution of blood pressure(Three years and three months.)
Evolution of lipid profile(Three years and three months.)