Study Completed

Diabetes Mellitus

Bayer Identifier:

10139

ClinicalTrials.gov Identifier:

NCT01010100

EudraCT Number:

Not Available

EU CT Number:

Not Available

Prevent/delay development of type 2 diabetes in subjects with impaired glucose homeostasis treated with Acarbose in Primary Care

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

40 - 75 Years

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

Trial summary

Enrollment Goal

204

Trial Dates

August 2000 - May 2007

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Acarbose (Precose/Glucobay, BAYG5421)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 1	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 4	Reus, 43203, Spain
Completed	Area Bàsica de Salud Borges del Camp	Les Borges del Camp, 43350, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Cornudella	Cornudella, 43360, Spain
Completed	Area Bàsica de Salud Constantí	Constanti, 43120, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Centre d'Atenció Primària El Temple	Tortosa, 43500, Spain
Completed	Centro de Salud Novelda (Area 17)	Novelda, 03660, Spain
Completed	Centro de Salud de Crevillente (Area 19)	Crevillente, Spain
Completed	Centro de Salud Begonte	Begonte, 27373, Spain
Completed	Centro de Salud Mar Báltico	Madrid, 28033, Spain
Completed	Area Bàsica de Salud Reus 2	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 1	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 1	Reus, 43202, Spain
Completed	Area Bàsica de Salud Reus 3 - CAP Sant Pere	Reus, 43201, Spain
Completed	Area Basica de Salud Vinebre	Vinebre, 43729, Spain
Completed	Area Bàsica de Salud Falset	Falset, 43730, Spain
Completed	Area Bàsica de Salud Torreforta - La Granja	Tarragona, 43006, Spain
Completed	Area Bàsica de Salud El Morell	El Morell, 43760, Spain
Completed	Centre d'Atenció Primària Jaume I	Tarragona, 43005, Spain
Completed	Centro de Salud Agost (Area 18)	Agost, 03698, Spain
Completed	Centro de Salud La Florida	Alicante, 03007, Spain
Completed	Centro de Salud San Vicente de Raspeig (Area 18)	San Vicente del Raspeig, 03690, Spain
Completed	Centro de Salud Villalba	Villalba, 27800, Spain
Completed	Centro de saluld de camas	Camas, 41900, Spain
Completed	Centro de Salud Trobajo del Camino	Trobajo del Camino, 24010, Spain
Completed	CAP Terrassa Sud	Terrassa, 08223, Spain

Primary Outcome

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.
Safety Issue:
no

Secondary Outcome

Regression to the normality (NO impaired glucose homeostasis)
Time Frame:
Proportion of subjects that had regressed to normality after three years of treatment.
Safety Issue:
no
Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)
Time Frame:
Three years and three months.
Safety Issue:
yes
Evolution of blood pressure
Time Frame:
Three years and three months.
Safety Issue:
yes
Evolution of lipid profile
Time Frame:
Three years and three months.
Safety Issue:
yes
Evolution of anthropometric measurements
Time Frame:
Three years and three months. (BMI)
Safety Issue:
yes
The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure
Time Frame:
Time until the appearance or progression of cardiovascular episodes
Safety Issue:
yes
Delay in the conversion to diabetes mellitus
Time Frame:
Time until the confirmation of the diagnosis of Diabetes Mellitus
Safety Issue:
no

Trial design

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)

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.