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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01010100
First received: October 26, 2009
Last updated: December 23, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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, 43005 | |
| Tarragona, Spain, 43006 | |
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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Acarbose |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013