Diabetes Mellitus, Type 2Phase 1NCT04065581
Bioequivalence Study for Acarbose/Metformin FDC
A Phase 1 study testing Acarbose/Metformin FDC(BAY81-9783), Glucobay and Glucophage in people with Diabetes Mellitus, Type 2, run by Bayer at 1 site in China.
Trial summary
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Acarbose/Metformin FDC(BAY81-9783), Glucobay and Glucophage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2019to 6 Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese healthy male or non-pregnant, non-lactating female subject, age ≥ 18 years at the first screening examination / visit.
- Body Mass Index (BMI): ≥ 19 to <28 kg / m*2 , with body weight ≥ 50 kg.
- Results of HbA1c value are within the normal range (4.0-6.0%, inclusive).
- Plasma glucose after 75g oral glucose loading show:
- FPG (Fast Plasma Glucose) < 6.1 mmol / dL.
- 2-h PG (Plasma Glucose 2 hours after glucose loading) < 7.8 mmol/dL
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- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time phase between signing of the informed consent form and the last visit. The acceptable methods of contraception available to men include, for example (e.g.) condoms with or without a spermicidal agent; the acceptable methods of contraception available to women include e.g. (a) diaphragm or cervical cap with spermicide; (b) intra-uterine device; (c) hormone-based contraception (only for the female partners of male subjects) One method has to be used by the man and one method by the female partner. No need to use two methods at the same time if subject or his female partner has been surgically sterilized ,
- Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
- Subjects must give their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
Who cannot join
- Screening test results likely to show inappropriateness for participation in this study:
- Any clinically relevant abnormality identified on the screening medical examination
- Systolic blood pressure < 90 or ≥ 140 mmHg (after at least 5 min in supine position)
- Diastolic blood pressure < 60 or ≥ 90 mmHg (after at least 5 min in supine position)
- Pulse rate < 50 or > 100 beats/min (after at least 5 min in supine position)
- Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTcB-interval over 450 msec
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- Positive results for hepatitis B virus surface antigen (hepatitis B surface antigene (HBsAg)), hepatitis C virus antibodies (anti-HCV) and human immune deficiency virus antibodies (human immunodeficiency virus antibodies (anti-HIV)) and treponema pallidum specific antibody.
- Positive urine drug screening
- Hemoglobin level lower than Lower limit of normal value
- Clinical laboratory results evaluated by the investigators to be clinically abnormal values
- A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems, such as malabsorption or maldigestion from gastrointestinal tract, liver cirrhosis, renal dysfunction, congestive heart failure, ischemic heart disease, malignant neoplasm), of the central nervous system (e.g. epilepsy), or other organs which are likely to show inappropriateness for participation in this study
- States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld's syndrome, major hernias, intestinal obstructions, and intestinal ulcers).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Any type of acute metabolic acidosis.
- 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
- Special diets or known hypersensitivity preventing the subjects from eating the standard meals during the study.
- Habitual medication including Chinese herbal drugs within 3 months before the screening
- Participation in another clinical trial within 3 months 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 the Loose Combination of Acarbose and Metformin Following Single Oral Dosing in Chinese Healthy Adult Male and Female Subjects
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg)
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Acarbose/Metformin FDC(BAY81-9783), Glucobay, Glucophage
- 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
Single dose: 50 mg acarbose/500 mg metformin tablet, oral
GlucobayDrug
Single dose: 50 mg tablet, oral
GlucophageDrug
Single dose: 500 mg tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-washout-treatment B | Experimental | Subject will receive a single oral dose of acarbose/metformin FDC (Treatment A, 50 mg acarbose/500 mg metformin) in period 1, followed by a single oral dose of 50mg acarbose and 500mg metformin as loose combination (Treatment B) in period 2. Washout interval between 2 treatment periods was at least 7 days. Receives: Drug: Acarbose/Metformin FDC(BAY81-9783); Drug: Glucobay; Drug: Glucophage |
| Treatment B-washout-treatment A | Experimental | Subject will receive a single oral dose of 50 mg acarbose and 500 mg metformin as loose combination (Treatment B) in period 1, followed by a single oral dose of acarbose/metformin FDC (Treatment A, 50mg acarbose/500 mg metformin) in period 2. Washout interval between 2 treatment periods was at least 7 days. Receives: Drug: Acarbose/Metformin FDC(BAY81-9783); Drug: Glucobay; Drug: Glucophage |
What is being measured
The primary outcome is the main question the study is designed to answer.
RatioCmax (serum glucose)
RatioCmax=Cmax,day1/ Cmax,day-1 Cmax,day-1: Maximum serum glucose after 75g sucrose loading on Day -1 Cmax,day1: Maximum serum glucose after 75g sucrose loading and single dose administration of study drug on Day 1
Measured: Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes
RatioAUC(0-4) (serum glucose)
RatioAUC(0-4)=AUC(0-4),day1/AUC(0-4),day-1 AUC (0-4),day1: AUC of serum glucose from time 0 to 4 hours on Day 1 AUC(0-4),day-1: AUC of serum glucose from time 0 to 4 hours on Day -1
Measured: Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes
Cmax (plasma metformin)
Cmax: Maximum observed drug concentration in measured matrix after single dose administration / maximum drug concentration in plasma after single dose administration
Measured: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
AUC (0-tlast) (plasma metformin)
AUC (0-tlast): AUC from time 0 to the last data point > LLOQ (lower limit of quantification)
Measured: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
AUC (plasma metformin)
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Measured: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
Secondary outcomes (1)
Frequency of TEAE (treatment-emergent adverse event）
Measured: Approximate 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start14 Oct 2019
- Primary completion25 Nov 2019
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065581
- Sponsor's protocol ID
- 19843
- Status last verified
- Apr 2020
- First submitted
- 20 Aug 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. 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 the Loose Combination of Acarbose and Metformin Following Single Oral Dosing in Chinese Healthy Adult Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04065581
- Acronym / sponsor ID
- 19843
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 22 Aug 2019 (actual)
- 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 this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-washout-treatment B | Experimental | Drug: Acarbose/Metformin FDC(BAY81-9783), Drug: Glucobay, Drug: GlucophageSubject will receive a single oral dose of acarbose/metformin FDC (Treatment A, 50 mg acarbose/500 mg metformin) in period 1, followed by a single oral dose of 50mg acarbose and 500mg metformin as loose combination (Treatment B) in period 2. Washout interval between 2 treatment periods was at least 7 days. |
| Treatment B-washout-treatment A | Experimental | Drug: Acarbose/Metformin FDC(BAY81-9783), Drug: Glucobay, Drug: GlucophageSubject will receive a single oral dose of 50 mg acarbose and 500 mg metformin as loose combination (Treatment B) in period 1, followed by a single oral dose of acarbose/metformin FDC (Treatment A, 50mg acarbose/500 mg metformin) in period 2. Washout interval between 2 treatment periods was at least 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chinese healthy male or non-pregnant, non-lactating female subject, age ≥ 18 years at the first screening examination / visit.
- Body Mass Index (BMI): ≥ 19 to <28 kg / m*2 , with body weight ≥ 50 kg.
- Results of HbA1c value are within the normal range (4.0-6.0%, inclusive).
- Plasma glucose after 75g oral glucose loading show:
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time phase between signing of the informed consent form and the last visit. The acceptable methods of contraception available to men include, for example (e.g.) condoms with or without a spermicidal agent; the acceptable methods of contraception available to women include e.g. (a) diaphragm or cervical cap with spermicide; (b) intra-uterine device; (c) hormone-based contraception (only for the female partners of male subjects) One method has to be used by the man and one method by the female partner. No need to use two methods at the same time if subject or his female partner has been surgically sterilized ,
Key exclusion criteria (20 listed)
- Screening test results likely to show inappropriateness for participation in this study:
- A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems, such as malabsorption or maldigestion from gastrointestinal tract, liver cirrhosis, renal dysfunction, congestive heart failure, ischemic heart disease, malignant neoplasm), of the central nervous system (e.g. epilepsy), or other organs which are likely to show inappropriateness for participation in this study
- States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld's syndrome, major hernias, intestinal obstructions, and intestinal ulcers).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Any type of acute metabolic acidosis.
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)Single dose: 50 mg acarbose/500 mg metformin tablet, oral | Drug | Treatment A-washout-treatment B, Treatment B-washout-treatment A |
| GlucobaySingle dose: 50 mg tablet, oral | Drug | Treatment A-washout-treatment B, Treatment B-washout-treatment A |
| GlucophageSingle dose: 500 mg tablet, oral | Drug | Treatment A-washout-treatment B, Treatment B-washout-treatment A |
Primary outcome
RatioCmax (serum glucose)
Time frame: Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes
RatioCmax=Cmax,day1/ Cmax,day-1 Cmax,day-1: Maximum serum glucose after 75g sucrose loading on Day -1 Cmax,day1: Maximum serum glucose after 75g sucrose loading and single dose administration of study drug on Day 1
RatioAUC(0-4) (serum glucose)
Time frame: Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes
RatioAUC(0-4)=AUC(0-4),day1/AUC(0-4),day-1 AUC (0-4),day1: AUC of serum glucose from time 0 to 4 hours on Day 1 AUC(0-4),day-1: AUC of serum glucose from time 0 to 4 hours on Day -1
Cmax (plasma metformin)
Time frame: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
Cmax: Maximum observed drug concentration in measured matrix after single dose administration / maximum drug concentration in plasma after single dose administration
AUC (0-tlast) (plasma metformin)
Time frame: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
AUC (0-tlast): AUC from time 0 to the last data point > LLOQ (lower limit of quantification)
AUC (plasma metformin)
Time frame: Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
1 secondary outcome
Frequency of TEAE (treatment-emergent adverse event）
Time frame: Approximate 20 days
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 13 Apr 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
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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.
The record lists no contact. Use the official record to reach the sponsor.
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), Glucobay and Glucophage in people with Diabetes Mellitus, Type 2, run by Bayer at 1 site in China.
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 9 inclusion and 20 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 13 Apr 2020. 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 China. 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?
RatioCmax (serum glucose) (time frame: Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes). The study lists 5 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 13 Apr 2020.