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)
2 other identifiers
interventional
204
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus
Started Aug 2000
Longer than P75 for phase_3 diabetes-mellitus
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedDecember 28, 2010
December 1, 2010
6.8 years
October 26, 2009
December 23, 2010
Conditions
Keywords
Outcome Measures
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.
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 (7)
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)
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Agost, Alicante, 03698, Spain
Unknown Facility
Alicante, Alicante, 03007, Spain
Unknown Facility
Crevillent, Alicante, Spain
Unknown Facility
Novelda, Alicante, 03660, Spain
Unknown Facility
San Vicent del Raspeig, Alicante, 03690, Spain
Unknown Facility
Terrassa, Barcelona, 08223, Spain
Unknown Facility
Trobajo del Camino, León, 24010, Spain
Unknown Facility
Begonte, Lugo, 27373, Spain
Unknown Facility
Villalba, Lugo, 27800, Spain
Unknown Facility
Madrid, Madrid, 28033, Spain
Unknown Facility
Camas, Sevilla, 41900, Spain
Unknown Facility
Constantí, Tarragona, 43120, Spain
Unknown Facility
Cornudella, Tarragona, 43360, Spain
Unknown Facility
el Morell, Tarragona, 43760, Spain
Unknown Facility
Falset, Tarragona, 43730, Spain
Unknown Facility
les Borges del Camp, Tarragona, 43350, Spain
Unknown Facility
Reus, Tarragona, 43201, Spain
Unknown Facility
Reus, Tarragona, 43202, Spain
Unknown Facility
Reus, Tarragona, 43203, Spain
Unknown Facility
Tarragona, Tarragona, 43005, Spain
Unknown Facility
Tarragona, Tarragona, 43006, Spain
Unknown Facility
Tortosa, Tarragona, 43500, Spain
Unknown Facility
Vinebre, Tarragona, 43729, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 26, 2009
First Posted
November 9, 2009
Study Start
August 1, 2000
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
December 28, 2010
Record last verified: 2010-12