Type 2 DiabetesPhase 3NCT00666458
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
A Phase 3 study testing saxagliptin and sitagliptin in people with Type 2 Diabetes, run by AstraZeneca at 87 sites in 9 countries.
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 sitagliptin 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?
- saxagliptin and sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 87 sitesin 9 countries
- Study dates
- Apr 2008to Mar 2009
- Phase
- Phase 3
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
Who cannot join
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- Insulin therapy within one year
- Previous treatment with DPP-4 inhibitor
Trial locations and contacts
87 sites in 9 countries.
87 sites in 9 countries
Sweden14 sites
Research Site
Borås
Research Site
Degeberga
Research Site
Finspång
Research Site
Gothenburg
Research Site
Jönköping
Research Site
Ödeshög
Research Site
Örebro
Research Site
Piteå
Research Site
Rättvik
Research Site
Skanör
Research Site
Timrå
Research Site
Trollhättan
Research Site
Uddevalla
Research Site
Umeå
Belgium11 sites
Research Site
Aalst, Belgium
Research Site
Bonheiden, Belgium
Research Site
Bruges
Research Site
Genk, Belgium
Research Site
Gozée, Belgium
Research Site
Hasselt, Belgium
Research Site
Liège, Belgium
Research Site
Saint-Médard, Belgium
Research Site
Sint-Gillis-Waas, Belgium
Research Site
Tessenderlo, Belgium
Research Site
Thuillies, Belgium
France11 sites
Research Site
Angers
Research Site
Château-Gontier
Research Site
Corbeil-Essonnes
Research Site
La Seyne-sur-Mer
Research Site
Laval
Research Site
Le Lavandou
Research Site
Montrevault
Research Site
Saint-Cyr
Research Site
Tiercé
Research Site
Toulon
Research Site
Witry-lès-Reims
Italy10 sites
Research Site
Bergamo, BG
Research Site
Chiavari, GE
Research Site
Foggia, FG
Research Site
Genova, GE
Research Site
Mercato San Severino, SA
Research Site
Olbia, OT
Research Site
Padova, PD
Research Site
Pordenone, PN
Research Site
Rozzano, MI
Research Site
Siena, SI
Norway10 sites
Research Site
Ålesund
Research Site
Elverum
Research Site
Halden
Research Site
Hamar
Research Site
Lierskogen
Research Site
Lillehammer
Research Site
Oslo
Research Site
Sandvika
Research Site
Strømmen
Research Site
Svelvik
South Africa10 sites
Research Site
Benoni, Gauteng
Research Site
Bloemfontein
Research Site
Cape Town, South Africa
Research Site
Cape Town, Western Cape
Research Site
Durban, South Africa
Research Site
Durban
Research Site
Johannesburg, Gauteng
Research Site
Johannesburg
Research Site
Kwa Zulu Natal
Research Site
Pretoria
Argentina9 sites
Research Site
Buenos Aires, Buenos Aires
Research Site
Caba
Research Site
Capital Federal
Research Site
Ciudad de Buenos Aires
Research Site
Córdoba
Research Site
Lanus, Buenos Aires
Research Site
Mar del Plata, Buenos Aires
Research Site
Rosario
Research Site
Santa Fe, Santa Fe Province
Denmark9 sites
Research Site
Aalborg
Research Site
Aarhus
Research Site
Christiansfeld
Research Site
Farsø
Research Site
Gentofte Municipality
Research Site
Hobro
Research Site
Kolding
Research Site
Rødovre Municipality
Research Site
Viborg
Mexico3 sites
Research Site
Guadalajara, Jalisco
Research Site
México, D.f.
Research Site
Monterrey
About this study
Official title: 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone
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 sitagliptin in addition with metformin.
- Conditions
- Type 2 Diabetes
- Being tested
- saxagliptin, sitagliptin
- Keywords
- Type 2 diabetes, 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.
saxagliptinDrug
Also called Onglyza
tablet, per oral, once daily
sitagliptinDrug
Also called Januvia
capsule, per oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | saxagliptin add-on to metformin Receives: Drug: saxagliptin |
| 2 | Active comparator | sitagliptin add-on to metformin Receives: Drug: sitagliptin |
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 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol 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, Week 18
Secondary outcomes (3)
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)
Measured: Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Measured: Baseline, Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Measured: Baseline, Week 18 (Last Observation Carried Forward)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 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.
- 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
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- André Scheen, Professor, Principal investigator, Clinical Pharmacology Unit, Liege, BelgiumPeter Öhman, MD, PhD, Study director, AstraZeneca, Wilmington, USADeborah Price, MSc, Study chair, AstraZeneca, Wilmington, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666458
- Sponsor's protocol ID
- D1680C00002
- Other IDs
- EudraCT number 2007-006095-11
- Status last verified
- Mar 2010
- First submitted
- 23 Apr 2008
- Last updated
- 15 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes