Clinical trial NCT00666458: 18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
metformin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-04-25
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
* Insulin therapy within one year
* Previous treatment with DPP-4 inhibitor

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
timeFrame: Week 18 (Last Observation Carried Forward)
measure: Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
timeFrame: Baseline, Week 18 (Last Observation Carried Forward)
measure: Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
timeFrame: Baseline, Week 18 (Last Observation Carried Forward)
Other outcomes:
Locations:
city: Lanus
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gozee
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Saint-medard
country: Belgium
facility: Research Site
city: Sint-gillis-waas
country: Belgium
facility: Research Site
city: Tessenderlo
country: Belgium
facility: Research Site
city: Thuillies
country: Belgium
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Arhus
country: Denmark
facility: Research Site
city: Christiansfeld
country: Denmark
facility: Research Site
city: Farso
country: Denmark
facility: Research Site
city: Gentofte
country: Denmark
facility: Research Site
city: Hobro
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Rodovre
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Chateau Gontier
country: France
facility: Research Site
city: Corbeil Essonnes
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Laval
country: France
facility: Research Site
city: Le Lavandou
country: France
facility: Research Site
city: Montrevault
country: France
facility: Research Site
city: Saint Cyr
country: France
facility: Research Site
city: Tierce
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Witry Les Reims
country: France
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Foggia
country: Italy
facility: Research Site
state: FG
city: Chiavari
country: Italy
facility: Research Site
state: GE
city: Genova
country: Italy
facility: Research Site
state: GE
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Olbia
country: Italy
facility: Research Site
state: OT
city: Padova
country: Italy
facility: Research Site
state: PD
city: Pordenone
country: Italy
facility: Research Site
state: PN
city: Mercato San Severino
country: Italy
facility: Research Site
state: SA
city: Siena
country: Italy
facility: Research Site
state: SI
city: Mexico
country: Mexico
facility: Research Site
state: D.f.
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
city: Alesund
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Halden
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Lierskogen
country: Norway
facility: Research Site
city: Lillehammer
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Sandvika
country: Norway
facility: Research Site
city: Strommen
country: Norway
facility: Research Site
city: Svelvik
country: Norway
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Kwa Zulu Natal
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Boras
country: Sweden
facility: Research Site
city: Degeberga
country: Sweden
facility: Research Site
city: Finspang
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Odeshog
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Pitea
country: Sweden
facility: Research Site
city: Rattvik
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Timra
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
Study officials:
affiliation: Clinical Pharmacology Unit, Liege, Belgium
name: André Scheen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Wilmington, USA
name: Peter Öhman, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Wilmington, USA
name: Deborah Price, MSc
role: STUDY_CHAIR
References: