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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Acarbose (Glucobay, BAYG5421); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03007
  • Madrid, Spain, 28033
  • Tarragona, Spain, 43005
  • Tarragona, Spain, 43006
  • Alicante
    • Agost, Alicante, Spain, 03698
    • Crevillente, Alicante, Spain
    • Novelda, Alicante, Spain, 03660
    • San Vicente del Raspeig, Alicante, Spain, 03690
  • Barcelona
    • Terrassa, Barcelona, Spain, 08223
  • León
    • Trobajo del Camino, León, Spain, 24010
  • Lugo
    • Begonte, Lugo, Spain, 27373
    • Villalba, Lugo, Spain, 27800
  • Sevilla
    • Camas, Sevilla, Spain, 41900
  • Tarragona
    • Constanti, Tarragona, Spain, 43120
    • Cornudella, Tarragona, Spain, 43360
    • El Morell, Tarragona, Spain, 43760
    • Falset, Tarragona, Spain, 43730
    • Les Borges del Camp, Tarragona, Spain, 43350
    • Reus, Tarragona, Spain, 43201
    • Reus, Tarragona, Spain, 43202
    • Reus, Tarragona, Spain, 43203
    • Tortosa, Tarragona, Spain, 43500
    • Vinebre, Tarragona, Spain, 43729

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Acarbose (Glucobay, BAYG5421); 50 mg TID
PLACEBO_COMPARATOR: Arm 2	Drug: Placebo; 50 mg TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (ACTUAL): May 1, 2007
• Study Completion (ACTUAL): May 1, 2007

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (ESTIMATE): November 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 28, 2010
• Last Update Submitted That Met QC Criteria: December 23, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic Disease; IGT Impaired Glucose Tolerance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: 10139 (Other Identifier: CTEP); PREDIAP