Diabetes Mellitus, Type IIPhase 1NCT01728740
Bioequivalence Study for Acarbose / Metformin FDC
A Phase 1 study testing Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421) and Metformin in people with Diabetes Mellitus, Type II, run by Bayer at 1 site in South Korea.
Trial summary
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421) and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 1
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
- Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
- Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
- Blood glucose before OGTT <110 mg/dL.
- Blood glucose 1 hour after glucose loading <180 mg/dL
- Blood glucose 2 hours after glucose loading <140 mg/dL
Who cannot join
- A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
- Febrile illness within 1 week before drug administration
- Family history of diabetes (within the second degree of relationship)
- Known drug hypersensitivity or idiosyncrasy
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Habitual medication including Chinese herbal drugs
Show all 10Show fewer
- Intake of any drugs within 2 weeks of drug administration of period 1
- Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
- Donation of more than 150 mL of blood within 4 weeks before the screening examination
- Participation in another clinical trial within 4 weeks before the screening examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421), Metformin
- Keywords
- Bioequivalence, Acarbose, Metformin, FDC
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose/Metformin FDC (BAY81-9783)Drug
Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
Acarbose (Glucobay, BAYG5421)Drug
Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
MetforminDrug
Metformin 500mg, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| Acarbose/Metformin FDC | Experimental | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin) Receives: Drug: Acarbose/Metformin FDC (BAY81-9783) |
| Acarbose+Metformin | Active comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg Receives: Drug: Acarbose (Glucobay, BAYG5421); Drug: Metformin |
| Acarbose | Active comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg Receives: Drug: Acarbose (Glucobay, BAYG5421) |
| Metformin | Active comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Measured: within 4 hours after sucrose load
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Measured: within 4 hours after sucrose load
Cmax of metformin
Measured: within 24 hours after dosing
AUC(0-tn) of metformin
Measured: within 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01728740
- Sponsor's protocol ID
- 15420
- Status last verified
- Dec 2012
- First submitted
- 14 Nov 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01728740
- Acronym / sponsor ID
- 15420
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Bioequivalence, Acarbose, Metformin, FDC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Nov 2012 (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.
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acarbose/Metformin FDC | Experimental | Drug: Acarbose/Metformin FDC (BAY81-9783)Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin) |
| Acarbose+Metformin | Active comparator | Drug: Acarbose (Glucobay, BAYG5421), Drug: MetforminDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg |
| Acarbose | Active comparator | Drug: Acarbose (Glucobay, BAYG5421)Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg |
| Metformin | Active comparator | Drug: MetforminDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
- Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
- Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
Key exclusion criteria (10 listed)
- A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
- Febrile illness within 1 week before drug administration
- Family history of diabetes (within the second degree of relationship)
- Known drug hypersensitivity or idiosyncrasy
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
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/Metformin FDC (BAY81-9783)Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose | Drug | Acarbose/Metformin FDC |
| Acarbose (Glucobay, BAYG5421)Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose | Drug | Acarbose, Acarbose+Metformin |
| MetforminMetformin 500mg, oral, single dose | Drug | Acarbose+Metformin, Metformin |
Primary outcome
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Time frame: within 4 hours after sucrose load
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Time frame: within 4 hours after sucrose load
Cmax of metformin
Time frame: within 24 hours after dosing
AUC(0-tn) of metformin
Time frame: within 24 hours after dosing
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 19 Dec 2012.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421) and Metformin in people with Diabetes Mellitus, Type II, run by Bayer at 1 site in South Korea.
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 6 inclusion and 10 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 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) (time frame: within 4 hours after sucrose load). The study lists 4 primary outcomes in all. 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 19 Dec 2012.