Type 2 DiabetesPhase 3SCORENCT00960076

An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

A Phase 3 study testing Saxagliptin and Metformin XR in people with Type 2 Diabetes, run by AstraZeneca at 35 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR. Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin and Metformin XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 35 sitesin 5 countries
Study dates: Aug 2009to Oct 2010
Phase: Phase 3
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 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
A1c: 7.5-11% (at screening)
BMI less than or equal to 45 kg/m2

Who cannot join

Significant cardiovascular history
Active liver disease, renal impairment

Trial locations and contacts

35 sites in 5 countries.

Country

City, postcode or hospital

35 sites in 5 countries

United States22 sites

Research Site
Alexandria, Virginia
Research Site
Anaheim, California
Research Site
Bristol, Tennessee
Research Site
Burke, Virginia
Research Site
Chicago, Illinois
Research Site
Columbus, Ohio
Research Site
Fountain Valley, California
Research Site
Gainesville, Florida
Research Site
Indianapolis, Indiana
Research Site
Jonesboro, Arkansas
Research Site
Los Angeles, California
Research Site
Manassas, Virginia
Research Site
Marion, Ohio
Research Site
Pasadena, California
Research Site
Sacramento, California
Research Site
Salisbury, North Carolina
Research Site
Simpsonville, South Carolina
Research Site
Springfield, Illinois
Research Site
St Louis, Missouri
Research Site
Wellington, Florida
Research Site
Wilmington, North Carolina
Research Site
Winston-Salem, North Carolina

Other trials in United States

Mexico6 sites

Research Site
Cuernavaca, Morelos
Research Site
Durango, Durango
Research Site
Guadalajara, Jalisco
Research Site
México, D.f.
Research Site
Querétaro City, Querétaro
Research Site
Zapopan, Jalisco

Other trials in Mexico

Colombia3 sites

Research Site
Barranquilla, Atlántico
Research Site
Barranquilla
Research Site
Bogotá

Other trials in Colombia

Costa Rica3 sites

Research Site
Curridabat, Provincia de San José
Research Site
Heredia
Research Site
Los Yoses, Provincia de San José

Other trials in Costa Rica

Peru1 site

Research Site
Lima

Other trials in Peru

About this study

Official title: 18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Metformin XR
Keywords: T2DM, Metformin, A1c
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
5mg oral tablet once daily
Metformin XRDrug
500mg oral tablet once daily
Metformin XRDrug
750mg, 2 tablets once daily

Study groups in NCT00960076
Study group	Role	What they receive
1	Experimental	Saxagliptin Receives: Drug: Saxagliptin; Drug: Metformin XR
2	Active comparator	Metformin Extended Release Receives: Drug: Metformin XR

What is being measured

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

Change in HbA1c Level From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Measured: Baseline to week 18

Secondary outcomes (3)

Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Measured: Baseline to week 18
Change in FPG From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Measured: Baseline to week 18
Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)
Measured: Week 18 (LOCF)

Timeline

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

Aug 2009Oct 2010

First posted17 Aug 2009 (estimated)
Study startAug 2009
Primary completionOct 2010
Study completionOct 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00960076
Sponsor's protocol ID: D1680L00005
Acronym: SCORE
Status last verified: Aug 2011
First submitted: 14 Aug 2009
Last updated: 27 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fonseca V, Zhu T, Karyekar C, Hirshberg B. Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage. Diabetes Obes Metab. 2012 Apr;14(4):365-71. doi: 10.1111/j.1463-1326.2011.01553.x. Epub 2012 Jan 18.
PubMed 22192246

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg
ClinicalTrials.gov ID: NCT00960076
Acronym / sponsor ID: SCORE / D1680L00005
Conditions: Type 2 Diabetes
Keywords: T2DM, Metformin, A1c
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Aug 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 17 Aug 2009 (estimated)
Results: Posted 27 Sep 2011

Clinical summary

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

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Saxagliptin, Drug: Metformin XRSaxagliptin
2	Active comparator	Drug: Metformin XRMetformin Extended Release

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
A1c: 7.5-11% (at screening)
BMI less than or equal to 45 kg/m2

Key exclusion criteria (2 listed)

Significant cardiovascular history
Active liver disease, renal impairment

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: Onglyza5mg oral tablet once daily	Drug	1
Metformin XR500mg oral tablet once daily	Drug	2
Metformin XR750mg, 2 tablets once daily	Drug	1, 2

Primary outcome

Change in HbA1c Level From Baseline to Week 18 (LOCF)
Time frame: Baseline to week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

3 secondary outcomes

Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
Time frame: Baseline to week 18
Change in FPG From Baseline to Week 18 (LOCF)
Time frame: Baseline to week 18
Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
Time frame: Week 18 (LOCF)

Results and safety

Results posted to the registry on 27 Sep 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
Saxagliptin + Metformin	138	130
Metformin (DB) + Metformin (OL)	144	119

Primary outcome: Change in HbA1c Level From Baseline to Week 18 (LOCF)

Time frame: Baseline to week 18. Mean (Standard Error). Unit: Percent

Measure	Saxagliptin + Metformin n = 137	Metformin (DB) + Metformin (OL) n = 142
Baseline	8.41 (0.076)	8.28 (0.077)
Week 18	7.53 (0.093)	7.93 (0.111)
Adjusted Change from Baseline to Week 18	-0.88 (0.077)	-0.35 (0.076)

Saxagliptin + Metformin vs Metformin (DB) + Metformin (OL): Mean Difference (Net): -0.52 (95% CI -0.73 to -0.31)

3 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
Saxagliptin + Metformin	0 of 138 (0%)	21 of 138 (15.2%)	Not reported
Metformin (DB) + Metformin (OL)	3 of 144 (2.1%)	16 of 144 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22192246Fonseca V, Zhu T, Karyekar C, Hirshberg B. Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage. Diabetes Obes Metab. 2012 Apr;14(4):365-71. doi: 10.1111/j.1463-1326.2011.01553.x. Epub 2012 Jan 18.

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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.

Boaz Hirschberg, MD study director

AstraZeneca

Vivian Fonseca, MD principal investigator

Tulane University

35 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin and Metformin XR in people with Type 2 Diabetes, run by AstraZeneca at 35 sites in 5 countries.

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 2 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 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Mexico, Colombia, Costa Rica, Peru. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Sep 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?

Change in HbA1c Level From Baseline to Week 18 (LOCF) (time frame: Baseline to week 18). 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 NCT00960076, 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 27 Sep 2011.