Type 2 Diabetes MellitusPhase 1NCT00897390

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

A Phase 1 study testing Saxagliptin, Metformin IR (glucophage) and Saxagliptin + Metformin IR (FDC) 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/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 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?: Saxagliptin, Metformin IR (glucophage) and Saxagliptin + Metformin IR (FDC)
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 Jul 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 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

SaxagliptinDrug
Also called Onglyza
Tablet, Oral, 2.5 mg, Once Daily, 1 week
Metformin IR (glucophage)Drug
Also called Glucophage
Tablets, Oral, 1000 mg, Once Daily, 1 week
Saxagliptin + Metformin IR (FDC)Drug
Also called Onglyza, Glucophage
Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week

Study groups in NCT00897390
Study group	Role	What they receive
Arm A	Other	Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions Receives: Drug: Saxagliptin; Drug: Metformin IR (glucophage)
Arm B	Other	Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions Receives: Drug: Saxagliptin + Metformin IR (FDC)
Arm C	Other	Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal Receives: Drug: Saxagliptin; Drug: Metformin IR (glucophage)
Arm D	Other	Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal Receives: Drug: Saxagliptin + Metformin IR (FDC)

What is being measured

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

Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Metformin PK Parameter AUC(INF)
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Metformin PK Parameter AUC(0-T)
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Metformin PK Parameter Cmax
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Metformin PK Parameter T-HALF
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Metformin PK Parameter Tmax
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period

Secondary outcomes (10)

BMS-510849 PK Parameter AUC(INF)
Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter AUC(0-T)
Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter Cmax
Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter T-Half
Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter T-Max
Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.
Measured: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is 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, or is an important medical event.
Measured: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.
AEs of Special Interest
See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class [SOC]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity.
Measured: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).
Number of Participants With Marked Laboratory Abnormalities (MA)
Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10^3 c/uL; absolute neutrophils/bands LN, 1.500x10^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L.
Measured: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.
Number of Participants With Marked Urinalysis Abnormalities
Protein, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Glucose, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Blood, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). White Blood Cell (WBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). Red Blood Cell (RBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.)
Measured: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.
Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities
12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs.
Measured: At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation

Timeline

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

Jun 2009Jul 2009

First posted12 May 2009 (estimated)
Study startJun 2009
Primary completionJul 2009
Study completionJul 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: NCT00897390
Sponsor's protocol ID: CV181-092
Status last verified: May 2015
First submitted: 8 May 2009
Last updated: 21 May 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 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 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
ClinicalTrials.gov ID: NCT00897390
Acronym / sponsor ID: CV181-092
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: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 12 May 2009 (estimated)
Results: Posted 21 Jan 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
Arm A	Other	Drug: Saxagliptin, Drug: Metformin IR (glucophage)Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
Arm B	Other	Drug: Saxagliptin + Metformin IR (FDC)Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
Arm C	Other	Drug: Saxagliptin, Drug: Metformin IR (glucophage)Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
Arm D	Other	Drug: Saxagliptin + Metformin IR (FDC)Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal

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
SaxagliptinAlso: OnglyzaTablet, Oral, 2.5 mg, Once Daily, 1 week	Drug	Arm A, Arm C
Metformin IR (glucophage)Also: GlucophageTablets, Oral, 1000 mg, Once Daily, 1 week	Drug	Arm A, Arm C
Saxagliptin + Metformin IR (FDC)Also: Onglyza, GlucophageTablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week	Drug	Arm B, Arm D

Primary outcome

Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Metformin PK Parameter AUC(INF)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter AUC(0-T)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter Cmax
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter T-HALF
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter Tmax
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.

10 secondary outcomes

BMS-510849 PK Parameter AUC(INF)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter AUC(0-T)
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter Cmax
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter T-Half
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
BMS-510849 PK Parameter T-Max
Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs
Time frame: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.
AEs of Special Interest
Time frame: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).
Number of Participants With Marked Laboratory Abnormalities (MA)
Time frame: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.
Number of Participants With Marked Urinalysis Abnormalities
Time frame: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.
Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities
Time frame: At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation

Results and safety

Results posted to the registry on 21 Jan 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
All Treated Participants	24	18

Primary outcome: Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])

Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period. Geometric mean (Full Range). Unit: ng*h/mL

Measure	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted n = 19	FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted n = 19	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed n = 21	FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed n = 22
Value	47.25 (30.6 to 66.0)	48.91 (28.7 to 80.7)	52.89 (37.4 to 75.1)	51.11 (34.2 to 73.7)

2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted vs FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted: adjusted geometric mean: 1.042 (90% CI 1.009 to 1.075)
2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed vs FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed: adjusted geometric mean: 0.988 (90% CI 0.958 to 1.019)

Population analysed: Treated participants with PK measures

Primary outcome: Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])

Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period. Geometric mean (Full Range). Unit: ng*h/mL

Measure	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted n = 19	FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted n = 19	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed n = 21	FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed n = 22
Value	44.90 (29.1 to 64.3)	46.57 (27.8 to 77.7)	50.50 (35.6 to 73.2)	49.09 (33.5 to 71.3)

2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted vs FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted: adjusted geometric mean: 1.045 (90% CI 1.013 to 1.077)
2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed vs FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed: adjusted geometric mean: 0.992 (90% CI 0.962 to 1.022)

Population analysed: Treated participants with PK measures

Primary outcome: Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)

Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period. Geometric mean (Full Range). Unit: ng/mL

Measure	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted n = 19	FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted n = 19	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed n = 21	FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed n = 22
Value	8.58 (5.2 to 15.5)	9.09 (5.5 to 17.1)	10.97 (7.6 to 18.2)	10.80 (7.4 to 15.9)

2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted vs FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted: adjusted geometric mean: 1.077 (90% CI 0.978 to 1.185)
2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed vs FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed: adjusted geometric mean: 0.987 (90% CI 0.900 to 1.083)

Population analysed: Treated participants with PK measures

Primary outcome: Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)

Time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period. Mean (Standard Deviation). Unit: hours

Measure	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted n = 19	FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted n = 19	2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed n = 21	FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed n = 22
Value	6.66 (1.185)	6.34 (0.941)	6.47 (1.529)	5.78 (1.333)

Population analysed: Treated participants with PK measures

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted	0 of 19 (0%)	3 of 19 (15.8%)	Not reported
FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted	0 of 19 (0%)	2 of 19 (10.5%)	Not reported
2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed	0 of 21 (0%)	2 of 21 (9.5%)	Not reported
FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
Not Dosed	0 of 34 (0%)	0 of 34 (0%)	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 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?

A Phase 1 study testing Saxagliptin, Metformin IR (glucophage) and Saxagliptin + Metformin IR (FDC) in people with Type 2 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 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 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 21 Jan 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 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) (time frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period). The study lists 10 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 NCT00897390, 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.