Diabetes MellitusPhase 3NCT01010100
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
A Phase 3 study testing Acarbose (Glucobay, BAYG5421) in people with Diabetes Mellitus, run by Bayer at 23 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Acarbose (Glucobay, BAYG5421)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 23 sitesSpain
- Study dates
- Aug 2000to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Study site
Agost, Alicante, 03698
Study site
Alicante, Alicante, 03007
Study site
Begonte, Lugo, 27373
Study site
Camas, Sevilla, 41900
Study site
Constantí, Tarragona, 43120
Study site
Cornudella, Tarragona, 43360
Study site
Crevillent, Alicante
Study site
el Morell, Tarragona, 43760
Study site
Falset, Tarragona, 43730
Study site
les Borges del Camp, Tarragona, 43350
Study site
Madrid, Madrid, 28033
Study site
Novelda, Alicante, 03660
Study site
Reus, Tarragona, 43201
Study site
Reus, Tarragona, 43202
Study site
Reus, Tarragona, 43203
Study site
San Vicent del Raspeig, Alicante, 03690
Study site
Tarragona, Tarragona, 43005
Study site
Tarragona, Tarragona, 43006
Study site
Terrassa, Barcelona, 08223
Study site
Tortosa, Tarragona, 43500
Study site
Trobajo del Camino, León, 24010
Study site
Villalba, Lugo, 27800
Study site
Vinebre, Tarragona, 43729
About this study
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)
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Acarbose (Glucobay, BAYG5421), Placebo
- Keywords
- Metabolic Disease, IGT Impaired Glucose Tolerance
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose (Glucobay, BAYG5421)Drug
50 mg TID
PlaceboDrug
50 mg TID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acarbose (Glucobay, BAYG5421) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
Regression to the normality (NO impaired glucose homeostasis)
Measured: Proportion of subjects that had regressed to normality after three years of treatment.
Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)
Measured: Three years and three months.
Evolution of blood pressure
Measured: Three years and three months.
Evolution of lipid profile
Measured: Three years and three months.
Evolution of anthropometric measurements
Measured: Three years and three months. (BMI)
The appearance or progression of cardiovascular events: angina, myocardial infarction, cerebrovascular accident, congestive heart failure, peripheral vascular disease, revascularisation procedure
Measured: Time until the appearance or progression of cardiovascular episodes
Delay in the conversion to diabetes mellitus
Measured: Time until the confirmation of the diagnosis of Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startAug 2000
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010100
- Sponsor's protocol ID
- 10139
- Other IDs
- PREDIAP
- Status last verified
- Dec 2010
- First submitted
- 26 Oct 2009
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01010100
- Acronym / sponsor ID
- 10139
- Conditions
- Diabetes Mellitus
- Keywords
- Metabolic Disease, IGT Impaired Glucose Tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acarbose (Glucobay, BAYG5421) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose (Glucobay, BAYG5421)50 mg TID | Drug | Arm 1 |
| Placebo50 mg TID | Drug | Arm 2 |
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.
7 secondary outcomes
Regression to the normality (NO impaired glucose homeostasis)
Time frame: Proportion of subjects that had regressed to normality after three years of treatment.
Evolution of the cardiovascular risk markers (microalbuminuria, triglycerides, fasting glycaemia, after overload glycaemia, HbA1c, C-peptide, insulinemia)
Time frame: Three years and three months.
Evolution of blood pressure
Time frame: Three years and three months.
Evolution of lipid profile
Time frame: Three years and three months.
Evolution of anthropometric measurements
Time frame: Three years and three months. (BMI)
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
Delay in the conversion to diabetes mellitus
Time frame: Time until the confirmation of the diagnosis of Diabetes Mellitus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acarbose (Glucobay, BAYG5421) in people with Diabetes Mellitus, run by Bayer at 23 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.