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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01010100
First received: October 26, 2009
Last updated: December 23, 2010
Last verified: December 2010
  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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Acarbose (Glucobay, BAYG5421)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regression to the normality (NO impaired glucose homeostasis) [ Time Frame: Proportion of subjects that had regressed to normality after three years of treatment. ] [ Designated as 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. ] [ Designated as safety issue: Yes ]
  • Evolution of blood pressure [ Time Frame: Three years and three months. ] [ Designated as safety issue: Yes ]
  • Evolution of lipid profile [ Time Frame: Three years and three months. ] [ Designated as safety issue: Yes ]
  • Evolution of anthropometric measurements [ Time Frame: Three years and three months. (BMI) ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Delay in the conversion to diabetes mellitus [ Time Frame: Time until the confirmation of the diagnosis of Diabetes Mellitus ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: August 2000
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acarbose (Glucobay, BAYG5421)
50 mg TID
Placebo Comparator: Arm 2 Drug: Placebo
50 mg TID

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010100

Locations
Spain
Agost, Alicante, Spain, 03698
Crevillente, Alicante, Spain
Novelda, Alicante, Spain, 03660
San Vicente del Raspeig, Alicante, Spain, 03690
Terrassa, Barcelona, Spain, 08223
Trobajo del Camino, León, Spain, 24010
Begonte, Lugo, Spain, 27373
Villalba, Lugo, Spain, 27800
Camas, Sevilla, Spain, 41900
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, 43203
Reus, Tarragona, Spain, 43202
Reus, Tarragona, Spain, 43201
Tortosa, Tarragona, Spain, 43500
Vinebre, Tarragona, Spain, 43729
Alicante, Spain, 03007
Madrid, Spain, 28033
Tarragona, Spain, 43006
Tarragona, Spain, 43005
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01010100     History of Changes
Other Study ID Numbers: 10139, PREDIAP
Study First Received: October 26, 2009
Last Updated: December 23, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Metabolic Disease
IGT Impaired Glucose Tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Acarbose
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014