Clinical trial NCT00960076: An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: T2DM
Metformin
A1c
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-08-17
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Significant cardiovascular history
* Active liver disease, renal impairment

Primary outcomes:
measure: Change in HbA1c Level From Baseline to Week 18 (LOCF)
timeFrame: Baseline to week 18
Secondary outcomes:
measure: Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
timeFrame: Baseline to week 18
measure: Change in FPG From Baseline to Week 18 (LOCF)
timeFrame: Baseline to week 18
measure: Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
timeFrame: Week 18 (LOCF)
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Wellington
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Marion
country: United States
facility: Research Site
state: Ohio
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Alexandria
country: United States
facility: Research Site
state: Virginia
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Curridabat
country: Costa Rica
facility: Research Site
state: San Jose
city: Los Yoses
country: Costa Rica
facility: Research Site
state: San Jose
city: Heredia
country: Costa Rica
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: D.f.
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Durango
country: Mexico
facility: Research Site
city: Queretaro
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Boaz Hirschberg, MD
role: STUDY_DIRECTOR
affiliation: Tulane University
name: Vivian Fonseca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.