Type 2 DiabetesPhase 3NCT00575588

52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

A Phase 3 study testing Metformin, Sulphonylurea and Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 94 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Metformin, Sulphonylurea and Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 891 participants
Where: 94 sitesin 11 countries
Study dates: Dec 2007to Aug 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with type 2 diabetes,
Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
HbA1c >6.5% and ≤10.0%

Who cannot join

Type 1 diabetes,
history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Trial locations and contacts

94 sites in 11 countries.

Country

City, postcode or hospital

94 sites in 11 countries

Germany17 sites

Research Site
Aschaffenburg
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Berlin
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Dortmund
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Frankfurt
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Hamburg
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Hanover
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Mainz
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Mannheim
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Mülheim
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Pirna
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Ratzeburg
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Reinfeld
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Rhaunen
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Schmiedeberg
Research Site
Tübingen
Research Site
Wahlstedt
Research Site
Weinheim

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United Kingdom13 sites

Research Site
Annan, Dumfries and Galloway
Research Site
Blackpool
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Bradford on Avon, Wiltshire
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Coatbridge
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Coventry
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Crawley, West Sussex
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Glasgow
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Hamilton, Lanarkshire
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Motherwell
Research Site
Newcastle
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Salford, Manchester
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Sheffield
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Whitstable, Kent

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Hungary12 sites

Research Site
Balatonfüred
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Békéscsaba
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Budapest
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Debrecen
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Gyula
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Kalocsa
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Kaposvár
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Mosonmagyaróvár
Research Site
Nyíregyháza
Research Site
Székesfehérvár

Other trials in Hungary

Norway12 sites

Research Site
Bergen
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Elverum
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Flatåsen
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Hamar
Research Site
Hønefoss
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Inderoy
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Oslo
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Rådal
Research Site
Skedsmokorset
Research Site
Sogndal
Research Site
Spikkestad
Research Site
Trollåsen

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Netherlands11 sites

Research Site
's-Hertogenbosch
Research Site
Beek en Donk
Research Site
Deurne
Research Site
Dordrecht
Research Site
Losser
Research Site
Nijverdal
Research Site
Rijswijk
Research Site
Roelofarendsveen
Research Site
Rotterdam
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The Hague
Research Site
Volendam

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Finland7 sites

Research Site
Hanko
Research Site
Helsinki
Research Site
Kuopio
Research Site
Kuusankoski
Research Site
Mikkeli
Research Site
Oulu
Research Site
Tampere

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Slovakia6 sites

Research Site
Dolný Kubín
Research Site
Kosice - Tahanovce
Research Site
Moldava nad Bodvou
Research Site
Ružomberok
Research Site
Trnava
Research Site
Žilina

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South Korea6 sites

Research Site
Guri-si, Gyeonggi-do
Research Site
Incheon
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Uijeongbu-si
Research Site
Wŏnju, Gangwon-do

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Russia5 sites

Research Site
Kazan'
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Saint Petersburg
Research Site
Yaroslavl

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India4 sites

Research Site
Bangalore, Karnataka
Research Site
Indore, Madhya Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Mumbai, Mashatra

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Vietnam1 site

Research Site
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Conditions: Type 2 Diabetes
Being tested: Metformin, Sulphonylurea, Saxagliptin
Keywords: DPP-4 Inhibitors, HbA1c, incretins
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.

MetforminDrug
open-label metformin
SulphonylureaDrug
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
SaxagliptinDrug
Also called Onglyza
Saxagliptin 5 mg tablets

Study groups in NCT00575588
Study group	Role	What they receive
Saxagliptin	Experimental	Not described Receives: Drug: Metformin; Drug: Saxagliptin
Glipizide	Experimental	Not described Receives: Drug: Metformin; Drug: Sulphonylurea

What is being measured

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

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Measured: Baseline to 52 Weeks

Secondary outcomes (3)

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Measured: From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Measured: Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Measured: Week 24 to Week 52

Timeline

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

Dec 2007Aug 2010

First posted18 Dec 2007 (estimated)
Study startDec 2007
Primary completionAug 2009
Study completionAug 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 (3)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: 891 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575588
Sponsor's protocol ID: D1680C00001
Other IDs: EudraCT number 2007-003998-55
Status last verified: Mar 2012
First submitted: 14 Dec 2007
Last updated: 21 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
PubMed 25414932
Mintz ML, Minervini G. Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. Curr Med Res Opin. 2014 May;30(5):761-70. doi: 10.1185/03007995.2014.880674. Epub 2014 Jan 30.
PubMed 24397584
Goke B, Gallwitz B, Eriksson JG, Hellqvist A, Gause-Nilsson I. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract. 2013 Apr;67(4):307-16. doi: 10.1111/ijcp.12119.
PubMed 23638466

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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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
ClinicalTrials.gov ID: NCT00575588
Acronym / sponsor ID: D1680C00001
Conditions: Type 2 Diabetes
Keywords: DPP-4 Inhibitors, HbA1c, incretins
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 891 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Dec 2007
Primary completion: Aug 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 18 Dec 2007 (estimated)
Results: Posted 6 Sep 2010

Clinical summary

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

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
Saxagliptin	Experimental	Drug: Metformin, Drug: Saxagliptin
Glipizide	Experimental	Drug: Metformin, Drug: Sulphonylurea

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosed with type 2 diabetes,
Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
HbA1c >6.5% and ≤10.0%

Key exclusion criteria (3 listed)

Type 1 diabetes,
history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

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
Metforminopen-label metformin	Drug	Glipizide, Saxagliptin
SulphonylureaGlipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)	Drug	Glipizide
SaxagliptinAlso: OnglyzaSaxagliptin 5 mg tablets	Drug	Saxagliptin

Primary outcome

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Time frame: Baseline to 52 Weeks
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.

3 secondary outcomes

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Time frame: From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Time frame: Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Time frame: Week 24 to Week 52

Results and safety

Results posted to the registry on 6 Sep 2010, 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	428	165
Glipizide + Metformin	430	147

Primary outcome: Hemoglobin A1c (HbA1c) Change From Baseline to Week 52

Time frame: Baseline to 52 Weeks. Mean (Standard Error). Unit: Percent

Measure	Saxagliptin + Metformin n = 293	Glipizide + Metformin n = 293
Baseline	7.46 (0.045)	7.53 (0.045)
Week 52	6.74 (0.042)	6.71 (0.042)
Adjusted Change from Baseline to Week 52	-0.74 (0.038)	-0.80 (0.038)

Saxagliptin + Metformin vs Glipizide + Metformin: Mean Difference (Net): 0.06 (95% CI -0.05 to 0.16)

Population analysed: Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations

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	54 of 428 (12.6%)	105 of 428 (24.5%)	Not reported
Glipizide + Metformin	55 of 430 (12.8%)	201 of 430 (46.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25414932Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
Derived from this study: PubMed 24397584Mintz ML, Minervini G. Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. Curr Med Res Opin. 2014 May;30(5):761-70. doi: 10.1185/03007995.2014.880674. Epub 2014 Jan 30.
Derived from this study: PubMed 23638466Goke B, Gallwitz B, Eriksson JG, Hellqvist A, Gause-Nilsson I. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract. 2013 Apr;67(4):307-16. doi: 10.1111/ijcp.12119.

Related trials for Type 2 Diabetes

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Recruiting
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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.

Burkhard Goke principal investigator

University of Munich, Germany

Peter Ohman, MD study director

AstraZeneca

Deborah Price, MSc study chair

AstraZeneca

94 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin, Sulphonylurea and Saxagliptin in people with Type 2 Diabetes, run by AstraZeneca at 94 sites in 11 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 3 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, United Kingdom, Hungary, Norway, Netherlands and 6 more countries. 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 6 Sep 2010). 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?

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 (time frame: Baseline to 52 Weeks). 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 NCT00575588, which also lists 3 linked publications.

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 Mar 2012.