Type 2 Diabetes MellitusPhase 1NCT01365091

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

A Phase 1 study testing Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin and Metformin extended-release (XR) in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Brazil.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin and Metformin extended-release (XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteBrazil
Study dates: Jun 2011to Nov 2011
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women
women of childbearing potential who are using acceptable method of contraception
Women who are not pregnant or nursing
Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.

Who cannot join

Any significant acute or chronic medical illness.
History of gastrointestinal (GI) disease
Major surgery within 4 weeks of study drug administration
Any GI surgery that could impact study drug absorption
Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
Blood transfusion within 3 months of study drug administration for women and within 2 months for men

Show all 14Show fewer

Inability to be venipunctured and/or tolerate venous access
Current smoker or recent (within 1 month) history of regular tobacco use
Recent (within 6 months of study drug administration) drug or alcohol abuse
Participation in a bioequivalence study within the last 6 months of study drug administration
Estimated creatinine clearance of <80 mL/min using Cockcroft-Gault formula
History of allergy to drug class or related compounds
History of allergy to metformin or other similar acting agents
History of any significant drug allergy

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Local Institution
Campinas, São Paulo, 13073

Other trials in Brazil

About this study

Official title: Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR), Saxagliptin/Metformin FDC, Metformin
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.

Saxagliptin/metformin fixed-dose combination (FDC)Drug
Also called Onglyza/Glucophage extended release (XR)
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
SaxagliptinDrug
Also called Onglyza
Tablet, oral, 5 mg, once on Day 1 only, 1 day
Metformin extended-release (XR)Drug
Also called Glifage XR
Tablet, oral, 500 mg, once on Day 1 only, 1 day
Saxagliptin/Metformin FDCDrug
Also called Onglyza/Glucophage XR
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
MetforminDrug
Also called Glifage XR
Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Study groups in NCT01365091
Study group	Role	What they receive
Arm 1: Treatments A,B/B,A	Experimental	Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A). Receives: Drug: Saxagliptin/metformin fixed-dose combination (FDC); Drug: Saxagliptin; Drug: Metformin extended-release (XR)
Arm 2: Treatments C,D/D,C	Experimental	Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C). Receives: Drug: Saxagliptin/metformin fixed-dose combination (FDC); Drug: Saxagliptin; Drug: Metformin extended-release (XR)
Arm 3: Treatments E, F/F,E	Experimental	Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E). Receives: Drug: Saxagliptin; Drug: Saxagliptin/Metformin FDC; Drug: Metformin
Arm 4: Treatments G,H/H,G	Experimental	Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G). Receives: Drug: Saxagliptin; Drug: Saxagliptin/Metformin FDC; Drug: Metformin

What is being measured

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

Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
Measured: Days 1, 2, and 3 of Periods 1 and 2
AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
AUC=Area under the concentration-time curve
Measured: Days 1, 2, and 3 of Periods 1 and 2
AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
AUC=Area Under the Concentration-time Curve
Measured: Days 1, 2, and 3 of Periods 1 and 2

Secondary outcomes (1)

Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1

Timeline

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

Jun 2011Nov 2011

First posted3 Jun 2011 (estimated)
Study startJun 2011
Primary completionNov 2011
Study completionNov 2011

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.
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: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365091
Sponsor's protocol ID: CV181-162
Status last verified: Apr 2015
First submitted: 16 May 2011
Last updated: 8 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States
ClinicalTrials.gov ID: NCT01365091
Acronym / sponsor ID: CV181-162
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 19 Aug 2013

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 1: Treatments A,B/B,A	Experimental	Drug: Saxagliptin/metformin fixed-dose combination (FDC), Drug: Saxagliptin, Drug: Metformin extended-release (XR)Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A).
Arm 2: Treatments C,D/D,C	Experimental	Drug: Saxagliptin/metformin fixed-dose combination (FDC), Drug: Saxagliptin, Drug: Metformin extended-release (XR)Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C).
Arm 3: Treatments E, F/F,E	Experimental	Drug: Saxagliptin, Drug: Saxagliptin/Metformin FDC, Drug: MetforminPeriod 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E).
Arm 4: Treatments G,H/H,G	Experimental	Drug: Saxagliptin, Drug: Saxagliptin/Metformin FDC, Drug: MetforminPeriod 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy men and women
women of childbearing potential who are using acceptable method of contraception
Women who are not pregnant or nursing
Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.

Key exclusion criteria (14 listed)

Any significant acute or chronic medical illness.
History of gastrointestinal (GI) disease
Major surgery within 4 weeks of study drug administration
Any GI surgery that could impact study drug absorption
Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.

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
Saxagliptin/metformin fixed-dose combination (FDC)Also: Onglyza/Glucophage extended release (XR)Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day	Drug	Arm 1: Treatments A,B/B,A, Arm 2: Treatments C,D/D,C
SaxagliptinAlso: OnglyzaTablet, oral, 5 mg, once on Day 1 only, 1 day	Drug	Arm 1: Treatments A,B/B,A, Arm 2: Treatments C,D/D,C, Arm 3: Treatments E, F/F,E, Arm 4: Treatments G,H/H,G
Metformin extended-release (XR)Also: Glifage XRTablet, oral, 500 mg, once on Day 1 only, 1 day	Drug	Arm 1: Treatments A,B/B,A, Arm 2: Treatments C,D/D,C
Saxagliptin/Metformin FDCAlso: Onglyza/Glucophage XRTablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day	Drug	Arm 3: Treatments E, F/F,E, Arm 4: Treatments G,H/H,G
MetforminAlso: Glifage XRTablet, oral, 1000 mg, once on Day 1 only, 1 day	Drug	Arm 3: Treatments E, F/F,E, Arm 4: Treatments G,H/H,G

Primary outcome

Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
Time frame: Days 1, 2, and 3 of Periods 1 and 2
AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
Time frame: Days 1, 2, and 3 of Periods 1 and 2
AUC=Area under the concentration-time curve
AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
Time frame: Days 1, 2, and 3 of Periods 1 and 2
AUC=Area Under the Concentration-time Curve

1 secondary outcome

Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)
Time frame: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1

Results and safety

Results posted to the registry on 19 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Treatments A/B, B/A	28	26
Arm 2: Treatments C/D, D/C	28	26
Arm 3:Treatments E/ F, F/E	28	25
Arm 4: Treatments G/ H, H/G	28	25

Primary outcome: Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

Time frame: Days 1, 2, and 3 of Periods 1 and 2. Mean (Standard Deviation). Unit: μg/mL

Measure	Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted n = 25	Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed n = 26	Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted n = 24	Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed n = 25
Metformin Cmax (individual tablet)	713 (176)	654 (118)	1177 (399)	1077 (139)
Metformin Cmax (FDC)	678 (167)	577 (95)	1139 (325)	1091 (214)
Saxagliptin Cmax (individual tablet)	29274 (10209)	28339 (7339)	30914 (7965)	31319 (6270)
Saxagliptin Cmax (FDC)	31372 (11367)	28140 (8311)	33549 (7813)	29545 (6006)
5-OH Saxagliptin Cmax (individual tablets)	54709 (16816)	52628 (12850)	56444 (14731)	55177 (13751)
5-OH Saxagliptin Cmax (FDC)	56413 (15775)	11316 (45404)	59878 (15959)	54521 (12319)

Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted: Geometric mean ratio: 95.204 (90% CI 87.618 to 103.446), ANCOVA
Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted: Geometric mean ratio: 107.606 (90% CI 96.552 to 119.924), ANCOVA
Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted: Geometric mean ratio: 104.373 (90% CI 96.504 to 112.883)

Population analysed: Participants who received study medication and were evaluable

Primary outcome: AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

Time frame: Days 1, 2, and 3 of Periods 1 and 2. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting n = 25	Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed n = 26	Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting n = 24	Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed n = 25
Metformin AUC(0-T) (individual tablets)	5816 (1859)	5071 (821)	8174 (2394)	9628 (3270)
Metformin AUC(0-T) (FDC)	5386 (1896)	4701 (1028)	8500 (2713)	8936 (2696)
Saxagliptin AUC(0-T) (individual tablets)	106070 (26733)	110285 (22139)	102913 (22067)	124536 (24794)
Saxagliptin AUC(0-T) (FDC)	103865 (31088)	109345 (23947)	99215 (20146)	127232 (28709)
5-OH Saxagliptin AUC(0-T) (individual tablets)	320743 (68176)	305354 (53254)	324163 (59358)	9628 (3270)
5-OH Saxagliptin AUC(0-T) (FDC)	331332 (67491)	292515 (45404)	323039 (56031)	8936 (2696)

Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting: Geometric mean ratio: 91.508 (90% CI 82.596 to 101.380), ANCOVA
Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting: Geometric mean ratio: 97.437 (90% CI 93.889 to 101.119), ANCOVA
Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting: Geometric mean ratio: 96.770 (90% CI 93.350 to 100.316), ANCOVA

Population analysed: Participants who received study medication and were evaluable

Primary outcome: AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets

Time frame: Days 1, 2, and 3 of Periods 1 and 2. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted n = 25	Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed n = 26	Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted n = 24	Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed n = 25
Metformin AUC (0-inf) (individual tablets)	5877 (1858)	5127 (816)	8338 (2414)	9731 (3277)
Metformin AUC (0-inf) (FDC)	5443 (1905)	4754 (1037)	8618 (2726)	9054 (2684)
Saxagliptin AUC (0-inf) (individual tablets)	107425 (26828)	111677 (22315)	104293 (22149)	125820 (24856)
Saxagliptin AUC (0-inf) (FDC)	105248 (31314)	110705 (24091)	100620 (20264)	128602 (28729)
5-OH Saxagliptin AUC (0-inf) (individual tablets)	337345 (67941)	310983 (53447)	330247 (59863)	332495 (62192)
5-OH Saxagliptin AUC (0-inf) (FDC)	326501 (68475)	298037 (45636)	329085 (56298)	332869 (59469)

Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted: Geometric mean ratio: 91.494 (90% CI 82.697 to 101.226), ANCOVA
Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted: Geometric mean ratio: 97.477 (90% CI 93.955 to 101.132), ANCOVA
Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted: Geometric mean ratio: 96.760 (90% CI 93.393 to 100.247), ANCOVA

Population analysed: Participants who received study medication and were evaluable

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From screening through Day 1 to within 30 days of drug discontinuation on Day 1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting	0 of 28 (0%)	7 of 28 (25%)	Not reported
Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed	0 of 28 (0%)	13 of 26 (50%)	Not reported
Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting	0 of 28 (0%)	10 of 27 (37%)	Not reported
Saxagliptin, 5 mg/Metformin XR, 500 mg Fed	0 of 28 (0%)	6 of 26 (23.1%)	Not reported
Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting	0 of 28 (0%)	8 of 25 (32%)	Not reported
Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed	0 of 28 (0%)	4 of 27 (14.8%)	Not reported
Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting	0 of 28 (0%)	8 of 28 (28.6%)	Not reported
Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed	0 of 28 (0%)	14 of 28 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 4 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 8 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 Brazil. 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 19 Aug 2013). 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?

Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets (time frame: Days 1, 2, and 3 of Periods 1 and 2). The study lists 3 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 NCT01365091.

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 8 May 2015.