Type 2 Diabetes MellitusPhase 1NCT01068717

Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

A Phase 1 study testing Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) and Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) 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 the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states. Read more about this study

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, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) and Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Mar 2010
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

Men and women, aged 18 to 55 years, inclusive
Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
Body Mass Index of 18 to 32 kg/m^2, inclusive

Who cannot join

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 DPP-4 inhibitors or related compounds
History of allergy or intolerance to metformin or other similar acting agents
Previous exposure to saxagliptin
Exposure to metformin within 3 months pervious to study drug administration
Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula

Trial locations and contacts

1 site in 1 country.

United States1 site

Ppd Development, Lp
Austin, Texas, 78744

Other trials in United States

About this study

Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state), Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
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, 2.5 mg + Metformin, 500 mg (fasted state)Drug
Also called Onglyza™, Glucophage™
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)Drug
Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)Drug
Also called Onglyza™, Glucophage™
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)Drug
Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Study groups in NCT01068717
Study group	Role	What they receive
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)	Other	Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state Receives: Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)	Other	Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state Receives: Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)	Other	Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state Receives: Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)	Other	Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state Receives: Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)

What is being measured

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

Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Measured: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

Secondary outcomes (4)

Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.
Measured: At screening visit, at Day -1 of Periods 1 through 4, and at discharge
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
Measured: At screening visit, Day -1 of Period 1, and at study discharge
Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
Measured: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.

Timeline

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

Mar 2010Mar 2010

First posted15 Feb 2010 (estimated)
Study startMar 2010
Primary completionMar 2010
Study completionMar 2010

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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068717
Sponsor's protocol ID: CV181-118
Status last verified: Apr 2015
First submitted: 12 Feb 2010
Last updated: 12 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 12 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 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
ClinicalTrials.gov ID: NCT01068717
Acronym / sponsor ID: CV181-118
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 21 Oct 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
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)	Other	Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)	Other	Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)	Other	Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)	Other	Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state

Who may qualify

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

Key inclusion criteria (3 listed)

Men and women, aged 18 to 55 years, inclusive
Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
Body Mass Index of 18 to 32 kg/m^2, inclusive

Key exclusion criteria (8 listed)

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 DPP-4 inhibitors or related compounds
History of allergy or intolerance to metformin or other similar acting agents

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, 2.5 mg + Metformin, 500 mg (fasted state)Also: Onglyza™, Glucophage™Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week	Drug	Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week	Drug	Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)Also: Onglyza™, Glucophage™Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week	Drug	Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week	Drug	Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)

Primary outcome

Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4

4 secondary outcomes

Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
Time frame: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
Time frame: At screening visit, at Day -1 of Periods 1 through 4, and at discharge
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Time frame: At screening visit, Day -1 of Period 1, and at study discharge
Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
Time frame: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.

Results and safety

Results posted to the registry on 21 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Schedule ADBC	7	6
Treatment Schedule BACD	6	6
Treatment Schedule CBDA	7	7
Treatment Schedule DCAB	7	7

Primary outcome: Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States

Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A: Saxagliptin and Metformin Tablets, Fasted n = 27	Treatment B: Saxagliptin and Metformin FDC, Fasted n = 26	Treatment C: Saxagliptin and Metformin Tablets, Fed n = 26	Treatment D: Saxagliptin and Metformin FDC, Fed n = 26
Value	10.54 (26)	11.53 (26)	12.71 (36)	12.79 (37)

Treatment A: Saxagliptin and Metformin Tablets, Fasted vs Treatment B: Saxagliptin and Metformin FDC, Fasted: Ratio geometric least squares (LS) mean: 109.53 (90% CI 102.67 to 116.85)
Treatment C: Saxagliptin and Metformin Tablets, Fed vs Treatment D: Saxagliptin and Metformin FDC, Fed: Ratio geometric LS mean: 100.37 (90% CI 85.70 to 117.56)

Population analysed: All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.

Primary outcome: Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A: Saxagliptin and Metformin Tablets, Fasted n = 27	Treatment B: Saxagliptin and Metformin FDC, Fasted n = 26	Treatment C: Saxagliptin and Metformin Tablets, Fed n = 26	Treatment D: Saxagliptin and Metformin FDC, Fed n = 26
Value	1058.19 (23)	1044.70 (25)	810.08 (22)	811.94 (20)

Treatment A: Saxagliptin and Metformin Tablets, Fasted vs Treatment B: Saxagliptin and Metformin FDC, Fasted: Ratio geometric LS mean: 99.02 (90% CI 91.29 to 107.41)
Treatment C: Saxagliptin and Metformin Tablets, Fed vs Treatment D: Saxagliptin and Metformin FDC, Fed: Ratio geometric LS mean: 100.21 (90% CI 96.86 to 103.67)

Primary outcome: Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4. Mean (Standard Deviation). Unit: Hours

Measure	Treatment A: Saxagliptin + Metformin Tablets, Fasted n = 27	Treatment B: Saxagliptin/Metformin FDC, Fasted n = 26	Treatment C: Saxagliptin + Metformin Tablets, Fed n = 26	Treatment D: Saxagliptin/Metformin FDC, Fed n = 25
t1/2 saxagliptin	6.16 (1.06)	6.69 (0.90)	5.99 (0.91)	6.15 (0.79)
t1/2 metformin	11.05 (3.94)	13.02 (5.37)	10.72 (2.61)	10.96 (4.03)

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States

Time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment A: Saxagliptin and Metformin Tablets, Fasted n = 27	Treatment B: Saxagliptin and Metformin FDC, Fasted n = 26	Treatment C: Saxagliptin and Metformin Tablets, Fed n = 26	Treatment D: Saxagliptin and Metformin FDC, Fed n = 26
Value	50.28 (24)	51.60 (23)	59.00 (20)	58.94 (19)

Treatment A: Saxagliptin and Metformin Tablets, Fasted vs Treatment B: Saxagliptin and Metformin FDC, Fasted: Ratio geometric LS mean: 102.34 (90% CI 97.96 to 106.91)
Treatment C: Saxagliptin and Metformin Tablets, Fed vs Treatment D: Saxagliptin and Metformin FDC, Fed: Ratio geometric LS mean: 99.78 (90% CI 96.61 to 103.05)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fasted: 2.5mg Onglyza + 500mg Glucophage	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Fasted: 2.5mg Saxa/500mg Metformin FDC	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
Fed: 2.5mg Onglyza + 500mg Glucophage	0 of 26 (0%)	7 of 26 (26.9%)	Not reported
Fed: 2.5mg Saxa/500mg Metformin FDC	0 of 26 (0%)	4 of 26 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 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 3 inclusion and 8 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 12 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 Oct 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?

Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States (time frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4). 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 NCT01068717.

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 12 May 2015.