Diabetes MellitusPhase 1NCT01192139

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

A Phase 1 study testing saxagliptin, metformin XR and saxagliptin + metformin XR (FDC tablet) in people with Diabetes Mellitus, 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 demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus
What is being tested?: saxagliptin, metformin XR and saxagliptin + metformin XR (FDC tablet)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Dec 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
Ages 18 to 45, inclusive

Who cannot join

Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Major surgical procedure within 4 weeks prior to randomization
Positive serology test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
History of gastrointestinal disease within the past 3 months
Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator

Show all 14Show fewer

Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
Unable to tolerate oral and/or intravenous (IV) medications
Unable to tolerate the puncturing of veins for drawing of blood
Known allergy or hypersensitivity to any component of the study medication
History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization
Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization

Trial locations and contacts

1 site in 1 country.

United States1 site

Ppd Development, Lp
Austin, Texas, 78744

Other trials in United States

About this study

Official title: Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition

Read the detailed description

This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana)

Conditions: Diabetes Mellitus
Being tested: saxagliptin, metformin XR, saxagliptin + metformin XR (FDC tablet)
Medical subject headings: Diabetes Mellitus

What participants receive

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

saxagliptinDrug
Also called Onglyza
Tablets, Oral, 5 mg, once daily, Single dose
metformin XRDrug
Also called Glucophage XR
Tablets, Oral, 500 mg. once daily, Single dose
saxagliptin + metformin XR (FDC tablet)Drug
Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

Study groups in NCT01192139
Study group	Role	What they receive
5 mg saxagliptin + a single 500 mg metformin XR tablet	Experimental	Not described Receives: Drug: saxagliptin; Drug: metformin XR
FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed)	Experimental	under fed state Receives: Drug: saxagliptin + metformin XR (FDC tablet)
FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting)	Experimental	under fasted state Receives: Drug: saxagliptin + metformin XR (FDC tablet)

What is being measured

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

Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Saxagliptin Observed Maximum Plasma Concentration (Cmax)
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Metformin AUC(0-inf)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Metformin Cmax
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)

Secondary outcomes (16)

Saxagliptin Terminal Half-life (T1/2)
terminal half life; calculated as ln(2)/Kel
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-inf)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-t)
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 Cmax
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 T1/2
terminal half life; calculated as ln(2)/Kel
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 Tmax
Measured: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)
Measured: Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin AUC(0-t)
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.
Measured: Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin T1/2
terminal half life; calculated as ln(2)/Kel
Measured: Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin Tmax
Measured: Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])
Measured: Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.
Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities
Abnormalities considered by the investigator to be clinically significant and/or reported as an AE.
Measured: From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)

Timeline

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

Nov 2009Dec 2009

First posted31 Aug 2010 (estimated)
Study startNov 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01192139
Sponsor's protocol ID: CV181-111
Status last verified: May 2015
First submitted: 30 Aug 2010
Last updated: 21 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Boulton DW, Smith CH, Li L, Huang J, Tang A, LaCreta FP. Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult subjects. Clin Drug Investig. 2011;31(9):619-30. doi: 10.2165/11590290-000000000-00000.
PubMed 21819160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition
ClinicalTrials.gov ID: NCT01192139
Acronym / sponsor ID: CV181-111
Conditions: Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 31 Aug 2010 (estimated)
Results: Posted 17 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
5 mg saxagliptin + a single 500 mg metformin XR tablet	Experimental	Drug: saxagliptin, Drug: metformin XR
FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed)	Experimental	Drug: saxagliptin + metformin XR (FDC tablet)under fed state
FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting)	Experimental	Drug: saxagliptin + metformin XR (FDC tablet)under fasted state

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
Ages 18 to 45, inclusive

Key exclusion criteria (14 listed)

Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Major surgical procedure within 4 weeks prior to randomization
Positive serology test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
History of gastrointestinal disease within the past 3 months

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
saxagliptinAlso: OnglyzaTablets, Oral, 5 mg, once daily, Single dose	Drug	5 mg saxagliptin + a single 500 mg metformin XR tablet
metformin XRAlso: Glucophage XRTablets, Oral, 500 mg. once daily, Single dose	Drug	5 mg saxagliptin + a single 500 mg metformin XR tablet
saxagliptin + metformin XR (FDC tablet)Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose	Drug	FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting), FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed)

Primary outcome

Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Saxagliptin Observed Maximum Plasma Concentration (Cmax)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Metformin AUC(0-inf)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Metformin Cmax
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)

16 secondary outcomes

Saxagliptin Terminal Half-life (T1/2)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-inf)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-t)
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 Cmax
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 T1/2
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 Tmax
Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)
Time frame: Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin AUC(0-t)
Time frame: Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin T1/2
Time frame: Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Metformin Tmax
Time frame: Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)
Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])
Time frame: Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)
Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
Time frame: AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.
Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities
Time frame: From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)

Results and safety

Results posted to the registry on 17 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABC	5	5
Treatment Sequence ACB	5	5
Treatment Sequence BAC	5	5
Treatment Sequence BCA	5	5
Treatment Sequence CAB	5	5
Treatment Sequence CBA	5	5

Primary outcome: Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])

Time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing). Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Treatment A - Saxagliptin + Metformin XR, Fed n = 30	Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed n = 30	Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting n = 30
Value	107.28 (25.13)	111.72 (26.55)	103.35 (23.15)

Treatment A - Saxagliptin + Metformin XR, Fed vs Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed: Ratio of Geometric Least Squares Means: 1.039 (90% CI 1.011 to 1.068)
Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed vs Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting: Ratio of Least Squares Means: 1.078 (90% CI 1.049 to 1.108)
Treatment A - Saxagliptin + Metformin XR, Fed: Geometric least squares mean (ng*hr/mL): 104.65

Population analysed: All treated participants

Primary outcome: Saxagliptin Observed Maximum Plasma Concentration (Cmax)

Measure	Treatment A - Saxagliptin + Metformin XR, Fed n = 30	Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed n = 30	Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting n = 30
Value	26.84 (8.26)	27.25 (7.95)	28.85 (8.62)

Treatment A - Saxagliptin + Metformin XR, Fed vs Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed: Ratio of Geometric Least Squares Means: 1.021 (90% CI 0.940 to 1.109)
Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed vs Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting: Ratio of Geometric Least Squares Means: 0.949 (90% CI 0.873 to 1.031)
Treatment A - Saxagliptin + Metformin XR, Fed: Geometric least squares mean (ng*hr/mL): 25.68

Population analysed: All treated participants

Primary outcome: Metformin AUC(0-inf)

Measure	Treatment A - Saxagliptin + Metformin XR, Fed n = 25	Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed n = 24	Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting n = 23
Value	5865.92 (2357.15)	5516.97 (2423.08)	5073.70 (1406.45)

Treatment A - Saxagliptin + Metformin XR, Fed vs Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed: Ratio of Least Squares Geometric Means: 0.915 (90% CI 0.836 to 1.002)
Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed vs Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting: Ratio of Geometric LS Mean and 90% CI: 1.010 (90% CI 0.918 to 1.111)
Treatment A - Saxagliptin + Metformin XR, Fed: Geometric least squares mean (ng*hr/mL): 5542.2

Population analysed: Treated participants (the smaller sample size for AUC\[0-inf\] was due to the inability to estimate potassium chloride for some participants)

Primary outcome: Metformin Cmax

Measure	Treatment A - Saxagliptin + Metformin XR, Fed n = 30	Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed n = 30	Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting n = 30
Value	629.73 (160.14)	586.87 (150.63)	657.23 (187.67)

Treatment A - Saxagliptin + Metformin XR, Fed vs Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed: Ratio of Geometric Least Squares Means: 0.933 (95% CI 0.865 to 1.007)
Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed vs Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting: Ratio of Geometric Least Squares Means: 0.898 (90% CI 0.832 to 0.969)
Treatment A - Saxagliptin + Metformin XR, Fed: Geometric least squares mean (ng*hr/mL): 608.41

Population analysed: All treated participants

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 30 (0%)	3 of 30 (10%)	Not reported
Treatment C	0 of 30 (0%)	4 of 30 (13.3%)	Not reported
Treatment B	0 of 30 (0%)	2 of 30 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21819160Boulton DW, Smith CH, Li L, Huang J, Tang A, LaCreta FP. Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult subjects. Clin Drug Investig. 2011;31(9):619-30. doi: 10.2165/11590290-000000000-00000.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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 saxagliptin, metformin XR and saxagliptin + metformin XR (FDC tablet) in people with Diabetes Mellitus, 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 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 21 May 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?

Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) (time frame: Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)). 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?

On the ClinicalTrials.gov record for NCT01192139, which also lists 1 linked publication.

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 21 May 2015.