An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
SCORE
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
1 other identifier
interventional
282
4 countries
32
Brief Summary
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Aug 2009
Shorter than P25 for phase_3 type-2-diabetes
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
September 27, 2011
CompletedSeptember 27, 2011
August 1, 2011
1.2 years
August 14, 2009
June 30, 2011
August 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c Level From Baseline to Week 18 (LOCF)
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized 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 to week 18
Secondary Outcomes (3)
Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
Baseline to week 18
Change in FPG From Baseline to Week 18 (LOCF)
Baseline to week 18
Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
Week 18 (LOCF)
Study Arms (2)
1
EXPERIMENTALSaxagliptin
2
ACTIVE COMPARATORMetformin Extended Release
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant cardiovascular history
- Active liver disease, renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (35)
Research Site
Jonesboro, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Los Angeles, California, United States
Research Site
Pasadena, California, United States
Research Site
Sacramento, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Wellington, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
St Louis, Missouri, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Simpsonville, South Carolina, United States
Research Site
Bristol, Tennessee, United States
Research Site
Alexandria, Virginia, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Barranquilla, Atlántico, Colombia
Research Site
Barranquilla, Colombia
Research Site
Bogotá, Colombia
Research Site
Curridabat, Provincia de San José, Costa Rica
Research Site
Los Yoses, Provincia de San José, Costa Rica
Research Site
Heredia, Costa Rica
Research Site
México, D.f., Mexico
Research Site
Durango, Durango, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Cuernavaca, Morelos, Mexico
Research Site
Querétaro City, Querétaro, Mexico
Research Site
Lima, Peru
Related Publications (1)
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.
PMID: 22192246DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Boaz Hirschberg, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Vivian Fonseca, MD
Tulane University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
September 27, 2011
Results First Posted
September 27, 2011
Record last verified: 2011-08