Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care

Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010100
• Other study ID #: 10139
• Secondary ID: PREDIAP
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2009
• Last updated: December 23, 2010
• Start date: August 2000
• Est. completion date: May 2007

Study information

• Verified date: December 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Acarbose (Glucobay, BAYG5421)
50 mg TID
• Placebo
50 mg TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Regression to the normality (NO impaired glucose homeostasis)		Proportion of subjects that had regressed to normality after three years of treatment.	No
Secondary	Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)		Three years and three months.	Yes
Secondary	Evolution of blood pressure		Three years and three months.	Yes
Secondary	Evolution of lipid profile		Three years and three months.	Yes
Secondary	Evolution of anthropometric measurements		Three years and three months. (BMI)	Yes
Secondary	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	Yes
Secondary	Delay in the conversion to diabetes mellitus		Time until the confirmation of the diagnosis of Diabetes Mellitus	No

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