Type 2 Diabetes MellitusPhase 1NCT00899470

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)

A Phase 1 study testing Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting and Co-administration of Saxagliptin and Metformin IR, Fed in people with Type 2 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

To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state. Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting and Co-administration of Saxagliptin and Metformin IR, Fed
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 siteUnited States
Study dates: Jun 2009to Aug 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 19 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women ages 19 to 45 inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Who cannot join

Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
History of allergy or intolerance to metformin or other similar acting agents

Show all 9Show fewer

Prior exposure to saxagliptin
Prior exposure to metformin within 3 months of study drug administration.
Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula

Trial locations and contacts

1 site in 1 country.

United States1 site

Mds Pharma Services
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 500 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State

Conditions: Type 2 Diabetes Mellitus
Being tested: Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed, Saxagliptin/Metformin, Fed
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.

Co-administration of Saxagliptin and Metformin IR, FastedDrug
Also called Onglyza
Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
Saxagliptin/Metformin, FastingDrug
Also called Onglyza, Glucophage
Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
Co-administration of Saxagliptin and Metformin IR, FedDrug
Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
Saxagliptin/Metformin, FedDrug
Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions

Study groups in NCT00899470
Study group	Role	What they receive
S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed)	Experimental	Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed]) Receives: Drug: Co-administration of Saxagliptin and Metformin IR, Fasted; Drug: Saxagliptin/Metformin, Fasting; Drug: Co-administration of Saxagliptin and Metformin IR, Fed; Drug: Saxagliptin/Metformin, Fed
S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed)	Experimental	Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed) Receives: Drug: Co-administration of Saxagliptin and Metformin IR, Fasted; Drug: Saxagliptin/Metformin, Fasting; Drug: Co-administration of Saxagliptin and Metformin IR, Fed; Drug: Saxagliptin/Metformin, Fed
S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted)	Experimental	Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted) Receives: Drug: Co-administration of Saxagliptin and Metformin IR, Fasted; Drug: Saxagliptin/Metformin, Fasting; Drug: Co-administration of Saxagliptin and Metformin IR, Fed; Drug: Saxagliptin/Metformin, Fed
S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)	Experimental	Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted) Receives: Drug: Co-administration of Saxagliptin and Metformin IR, Fasted; Drug: Saxagliptin/Metformin, Fasting; Drug: Co-administration of Saxagliptin and Metformin IR, Fed; Drug: Saxagliptin/Metformin, Fed

What is being measured

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

Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)
Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)
T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Metformin Mean Cmax
Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Metformin Mean AUC (0-T)
AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Metformin Mean AUC(0-INF)
AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Metformin T-half and T-max
T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr

Secondary outcomes (9)

BMS-510849 Mean Cmax
Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean AUC (0-T)
AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean AUC (0-INF)
AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean T-half and T-max
T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.
Measured: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Measured: From Day 1 through Day 45, including up to 56 days after last dose of study medication
Number of Participants With Laboratory Marked Abnormalities
High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+
Measured: From Day 1 through Day 45, including up to 56 days after last dose of study medication
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities
PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.
Measured: Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3
Number of Participants With Clinically Relevant Vital Sign Abnormalities
Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.
Measured: Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3
Number of Participant With Clinically Relevant Physical Examination Abnormalities
A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.
Measured: Screen, Period 1 Day -1, prior to discharge

Timeline

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

Jun 2009Aug 2009

First posted12 May 2009 (estimated)
Study startJun 2009
Primary completionAug 2009
Study completionAug 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 Type 2 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00899470
Sponsor's protocol ID: CV181-081
Status last verified: May 2015
First submitted: 8 May 2009
Last updated: 1 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Upreti VV, Keung CF, Boulton DW, Chang M, Li L, Tang A, Hsiang BC, Quamina-Edghill D, Frevert EU, Lacreta FP. Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects. Clin Drug Investig. 2013 May;33(5):365-74. doi: 10.1007/s40261-013-0075-z.
PubMed 23549864

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 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 500 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
ClinicalTrials.gov ID: NCT00899470
Acronym / sponsor ID: CV181-081
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 25 Mar 2011

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed)	Experimental	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted, Drug: Saxagliptin/Metformin, Fasting, Drug: Co-administration of Saxagliptin and Metformin IR, Fed, Drug: Saxagliptin/Metformin, FedParticipants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed)	Experimental	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted, Drug: Saxagliptin/Metformin, Fasting, Drug: Co-administration of Saxagliptin and Metformin IR, Fed, Drug: Saxagliptin/Metformin, FedParticipants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted)	Experimental	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted, Drug: Saxagliptin/Metformin, Fasting, Drug: Co-administration of Saxagliptin and Metformin IR, Fed, Drug: Saxagliptin/Metformin, FedParticipants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)	Experimental	Drug: Co-administration of Saxagliptin and Metformin IR, Fasted, Drug: Saxagliptin/Metformin, Fasting, Drug: Co-administration of Saxagliptin and Metformin IR, Fed, Drug: Saxagliptin/Metformin, FedParticipants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Men and women ages 19 to 45 inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Key exclusion criteria (9 listed)

Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds

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
Co-administration of Saxagliptin and Metformin IR, FastedAlso: OnglyzaParticipants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions	Drug	S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed), S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted), S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed), S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)
Saxagliptin/Metformin, FastingAlso: Onglyza, GlucophageParticipants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions	Drug	S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed), S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted), S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed), S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)
Co-administration of Saxagliptin and Metformin IR, FedParticipants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions	Drug	S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed), S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted), S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed), S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)
Saxagliptin/Metformin, FedParticipants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions	Drug	S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed), S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted), S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed), S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted)

Primary outcome

Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Metformin Mean Cmax
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Metformin Mean AUC (0-T)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Metformin Mean AUC(0-INF)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Metformin T-half and T-max
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.

9 secondary outcomes

BMS-510849 Mean Cmax
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean AUC (0-T)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean AUC (0-INF)
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
BMS-510849 Mean T-half and T-max
Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr
Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation
Time frame: From Day 1 through Day 45, including up to 56 days after last dose of study medication
Number of Participants With Laboratory Marked Abnormalities
Time frame: From Day 1 through Day 45, including up to 56 days after last dose of study medication
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities
Time frame: Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3
Number of Participants With Clinically Relevant Vital Sign Abnormalities
Time frame: Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3
Number of Participant With Clinically Relevant Physical Examination Abnormalities
Time frame: Screen, Period 1 Day -1, prior to discharge

Results and safety

Results posted to the registry on 25 Mar 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
S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)	6	6
S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)	6	6
S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)	6	6
S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)	6	6

Primary outcome: Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr. Mean (Standard Deviation). Unit: ng/mL

Measure	Coadministration of Saxagliptin and Metformin IR (Fasted) n = 24	Saxagliptin/Metformin FDC (Fasted) n = 24	Coadministration of Saxagliptin and Metformin IR (Fed) n = 24	Saxagliptin/Metformin FDC (Fed) n = 24
Value	8.57 (2.572)	8.61 (2.266)	11.36 (2.875)	11.51 (3.781)

Coadministration of Saxagliptin and Metformin IR (Fasted) vs Saxagliptin/Metformin FDC (Fasted): Geometric Mean Ratio, Test vs. Reference: 1.011 (90% CI 0.940 to 1.088), Mixed Models Analysis
Coadministration of Saxagliptin and Metformin IR (Fed) vs Saxagliptin/Metformin FDC (Fed): Geometric Mean Ratio, Test vs Reference: 0.999 (90% CI 0.929 to 1.075)

Population analysed: PK data set, all participants who received study drug

Primary outcome: Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}

Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Coadministration of Saxagliptin and Metformin IR (Fasted) n = 24	Saxagliptin/Metformin FDC (Fasted) n = 24	Coadministration of Saxagliptin and Metformin IR (Fed) n = 24	Saxagliptin/Metformin FDC (Fed) n = 24
Value	48.57 (12.864)	49.69 (12.330)	54.59 (12.407)	55.83 (12.735)

Coadministration of Saxagliptin and Metformin IR (Fasted) vs Saxagliptin/Metformin FDC (Fasted): Geometric Mean Ratio, Test vs. Reference: 1.029 (90% CI 0.993 to 1.066), Mixed Models Analysis
Coadministration of Saxagliptin and Metformin IR (Fed) vs Saxagliptin/Metformin FDC (Fed): Geometric Means Ratio: 1.021 (90% CI 0.986 to 1.058), Mixed Models Analysis

Population analysed: PK data set, all participants who received study drug

Primary outcome: Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])

Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Coadministration of Saxagliptin and Metformin IR (Fasted) n = 24	Saxagliptin/Metformin FDC (Fasted) n = 24	Coadministration of Saxagliptin and Metformin IR (Fed) n = 24	Saxagliptin/Metformin FDC (Fed) n = 24
Value	50.66 (13.322)	51.74 (12.736)	56.56 (12.778)	57.86 (13.222)

Coadministration of Saxagliptin and Metformin IR (Fasted) vs Saxagliptin/Metformin FDC (Fasted): Geometric Mean Ratio, Test vs. Reference: 1.027 (90% CI 0.990 to 1.066), Mixed Models Analysis
Coadministration of Saxagliptin and Metformin IR (Fed) vs Saxagliptin/Metformin FDC (Fed): Geometric Means Ratio Test vs. Reference: 1.022 (95% CI 0.985 to 1.060), Mixed Models Analysis

Population analysed: PK data set, all participants who received study drug

Primary outcome: Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)

Time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr. Mean (Standard Deviation). Unit: hours

Measure	Coadministration of Saxagliptin and Metformin IR (Fasted) n = 24	Saxagliptin/Metformin FDC (Fasted) n = 24	Coadministration of Saxagliptin and Metformin IR (Fed) n = 24	Saxagliptin/Metformin FDC (Fed) n = 24
T-half	5.86 (1.367)	5.55 (1.135)	5.75 (1.119)	5.72 (1.146)
T-max	1.78 (1.210)	1.23 (0.829)	1.37 (0.842)	1.42 (0.862)

Population analysed: PK data set, all participants who received study drug

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coadministration of Saxagliptin and Metformin IR (Fasted)	0 of 24 (0%)	6 of 24 (25%)	Not reported
Saxagliptin/Metformin FDC (Fasted)	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
Coadministration of Saxagliptin and Metformin IR (Fed)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Saxagliptin/Metformin FDC (Fed)	0 of 24 (0%)	1 of 24 (4.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23549864Upreti VV, Keung CF, Boulton DW, Chang M, Li L, Tang A, Hsiang BC, Quamina-Edghill D, Frevert EU, Lacreta FP. Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects. Clin Drug Investig. 2013 May;33(5):365-74. doi: 10.1007/s40261-013-0075-z.

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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?

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 9 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 1 Jun 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 25 Mar 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 Mean Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr). The study lists 8 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 NCT00899470, 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 1 Jun 2015.