Clinical trial NCT01010100: Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Metabolic Disease
IGT Impaired Glucose Tolerance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: Regression to the normality (NO impaired glucose homeostasis)
timeFrame: Proportion of subjects that had regressed to normality after three years of treatment.
measure: Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)
timeFrame: Three years and three months.
measure: Evolution of blood pressure
timeFrame: Three years and three months.
measure: Evolution of lipid profile
timeFrame: Three years and three months.
measure: Evolution of anthropometric measurements
timeFrame: Three years and three months. (BMI)
measure: The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure
timeFrame: Time until the appearance or progression of cardiovascular episodes
measure: Delay in the conversion to diabetes mellitus
timeFrame: Time until the confirmation of the diagnosis of Diabetes Mellitus
Other outcomes:
Locations:
city: Agost
country: Spain
state: Alicante
city: Crevillente
country: Spain
state: Alicante
city: Novelda
country: Spain
state: Alicante
city: San Vicente del Raspeig
country: Spain
state: Alicante
city: Terrassa
country: Spain
state: Barcelona
city: Trobajo del Camino
country: Spain
state: León
city: Begonte
country: Spain
state: Lugo
city: Villalba
country: Spain
state: Lugo
city: Camas
country: Spain
state: Sevilla
city: Constanti
country: Spain
state: Tarragona
city: Cornudella
country: Spain
state: Tarragona
city: El Morell
country: Spain
state: Tarragona
city: Falset
country: Spain
state: Tarragona
city: Les Borges del Camp
country: Spain
state: Tarragona
city: Reus
country: Spain
state: Tarragona
city: Reus
country: Spain
state: Tarragona
city: Reus
country: Spain
state: Tarragona
city: Tortosa
country: Spain
state: Tarragona
city: Vinebre
country: Spain
state: Tarragona
city: Alicante
country: Spain
city: Madrid
country: Spain
city: Tarragona
country: Spain
city: Tarragona
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: