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Clinical Trial Details

Trial ID: L3292
Source ID: NCT00666458
Associated Drug: Saxagliptin
Title: 18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00666458/results
Conditions: Type 2 Diabetes
Interventions: DRUG: saxagliptin|DRUG: sitagliptin
Outcome Measures: Primary: 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., Baseline, Week 18 | Secondary: 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), 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., 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., Baseline, Week 18 (Last Observation Carried Forward)
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 822
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-04
Completion Date: 2009-03
Results First Posted: 2010-04-15
Last Update Posted: 2010-04-15
Locations: Research Site, Lanus, Buenos Aires, Argentina|Research Site, Mar Del Plata, Buenos Aires, Argentina|Research Site, Buenos Aires, Argentina|Research Site, Caba, Argentina|Research Site, Capital Federal, Argentina|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Cordoba, Argentina|Research Site, Rosario, Argentina|Research Site, Santa Fe, Argentina|Research Site, Aalst, Belgium|Research Site, Bonheiden, Belgium|Research Site, Brugge, Belgium|Research Site, Genk, Belgium|Research Site, Gozee, Belgium|Research Site, Hasselt, Belgium|Research Site, Liege, Belgium|Research Site, Saint-medard, Belgium|Research Site, Sint-gillis-waas, Belgium|Research Site, Tessenderlo, Belgium|Research Site, Thuillies, Belgium|Research Site, Aalborg, Denmark|Research Site, Arhus, Denmark|Research Site, Christiansfeld, Denmark|Research Site, Farso, Denmark|Research Site, Gentofte, Denmark|Research Site, Hobro, Denmark|Research Site, Kolding, Denmark|Research Site, Rodovre, Denmark|Research Site, Viborg, Denmark|Research Site, Angers, France|Research Site, Chateau Gontier, France|Research Site, Corbeil Essonnes, France|Research Site, La Seyne Sur Mer, France|Research Site, Laval, France|Research Site, Le Lavandou, France|Research Site, Montrevault, France|Research Site, Saint Cyr, France|Research Site, Tierce, France|Research Site, Toulon, France|Research Site, Witry Les Reims, France|Research Site, Bergamo, BG, Italy|Research Site, Foggia, FG, Italy|Research Site, Chiavari, GE, Italy|Research Site, Genova, GE, Italy|Research Site, Rozzano, MI, Italy|Research Site, Olbia, OT, Italy|Research Site, Padova, PD, Italy|Research Site, Pordenone, PN, Italy|Research Site, Mercato San Severino, SA, Italy|Research Site, Siena, SI, Italy|Research Site, Mexico, D.f., Mexico|Research Site, Guadalajara, Jalisco, Mexico|Research Site, Monterrey, Mexico|Research Site, Alesund, Norway|Research Site, Elverum, Norway|Research Site, Halden, Norway|Research Site, Hamar, Norway|Research Site, Lierskogen, Norway|Research Site, Lillehammer, Norway|Research Site, Oslo, Norway|Research Site, Sandvika, Norway|Research Site, Strommen, Norway|Research Site, Svelvik, Norway|Research Site, Benoni, Gauteng, South Africa|Research Site, Johannesburg, Gauteng, South Africa|Research Site, Cape Town, Western Cape, South Africa|Research Site, Bloemfontein, South Africa|Research Site, Cape Town, South Africa|Research Site, Durban, South Africa|Research Site, Johannesburg, South Africa|Research Site, Kwa Zulu Natal, South Africa|Research Site, Pretoria, South Africa|Research Site, Boras, Sweden|Research Site, Degeberga, Sweden|Research Site, Finspang, Sweden|Research Site, Goteborg, Sweden|Research Site, Jonkoping, Sweden|Research Site, Odeshog, Sweden|Research Site, Orebro, Sweden|Research Site, Pitea, Sweden|Research Site, Rattvik, Sweden|Research Site, Skanor, Sweden|Research Site, Timra, Sweden|Research Site, Trollhattan, Sweden|Research Site, Uddevalla, Sweden|Research Site, Umea, Sweden
URL: https://clinicaltrials.gov/show/NCT00666458

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details