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DiabetesPhase 1NCT01874080

Bioequivalence Study

A Phase 1 study testing Saxagliptin/Metformin in people with Diabetes, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
Saxagliptin/Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Jun 2013to Jul 2013
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female subjects, 18-45 years of age
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
  • Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

Who cannot join

  • Any significant acute or chronic medical illness
  • Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
  • Gastrointestinal (GI) disease that could affect the absorption of study drug
  • Inability to tolerate oral medication
  • History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
  • Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icon Development Solutions

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects Under Fed Conditions

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

Read the detailed description

Primary Purpose:

Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions

Conditions
Diabetes
Being tested
Saxagliptin/Metformin
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saxagliptin/MetforminDrug

    Also called Kombiglyze XR

Study groups in NCT01874080
Study groupRoleWhat they receive
Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)ExperimentalSaxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2
Receives: Drug: Saxagliptin/Metformin
Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)ExperimentalSaxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2
Receives: Drug: Saxagliptin/Metformin
Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)ExperimentalSaxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2
Receives: Drug: Saxagliptin/Metformin
Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)ExperimentalSaxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2
Receives: Drug: Saxagliptin/Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    Cmax=Maximum observed plasma concentration

    CI=Confidence interval

    FDC=Fixed dosed combination

    XR=Extended release

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  2. Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  3. Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  4. Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  5. Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  6. Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

Secondary outcomes (6)

  1. Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  2. Terminal half life (T-HALF) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  3. Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  4. AUC(0-T) for 5-OH Saxagliptin (Treatments A, B, C, and D)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  5. AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D)

    Measured: 19 time points up to Day 3 of Periods 1 and 2

  6. Safety assessments based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

    Parameters will include:

    1. Serious adverse events
    2. Deaths
    3. Adverse events leading to discontinuation
    4. Number of subjects with potentially clinically significant changes in vital signs, electrocardiograms (ECGs) or safety laboratory findings defined as meeting marked abnormality criteria

    Measured: Up to Day 3 of Periods 1 and 2 and up to 30 days post discontinuation of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

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
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874080
Sponsor's protocol ID
CV181-208
Status last verified
Mar 2015
First submitted
6 Jun 2013
Last updated
23 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Saxagliptin/Metformin in people with Diabetes, run by AstraZeneca at 1 site in United States.

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 3 inclusion and 6 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 23 Apr 2015. 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 United States. 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?

Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon) (time frame: 19 time points up to Day 3 of Periods 1 and 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874080.

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 23 Apr 2015; AzTrials last refreshed its copy on 2 Nov 2026.

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