An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— SCORE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960076
• Other study ID #: D1680L00005
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2009
• Last updated: August 22, 2011
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: Institutional Review BoardColombia: National Institutes of HealthCosta Rica: Ethics CommitteeCosta Rica: Ministry of Health Costa RicaMexico: Ethics CommitteeMexico: Federal Commission for Protection Against Health RisksMexico: Federal Commission for Sanitary Risks ProtectionMexico: Ministry of HealthMexico: National Council of Science and TechnologyMexico: National Institute of Public Health, Health SecretariatUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
5mg oral tablet once daily
• Metformin XR
500mg oral tablet once daily
• Metformin XR
750mg, 2 tablets once daily

Locations

Country	Name	City	State
Colombia	Research Site	Barranquilla	Atlantico
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Costa Rica	Research Site	Curridabat	San Jose
Costa Rica	Research Site	Heredia
Costa Rica	Research Site	Los Yoses	San Jose
Mexico	Research Site	Cuernavaca	Morelos
Mexico	Research Site	Durango
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico	D.f.
Mexico	Research Site	Queretaro
Mexico	Research Site	Zapopan	Jalisco
Peru	Research Site	Lima
United States	Research Site	Alexandria	Virginia
United States	Research Site	Anaheim	California
United States	Research Site	Bristol	Tennessee
United States	Research Site	Burke	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Fountain Valley	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Manassas	Virginia
United States	Research Site	Marion	Ohio
United States	Research Site	Pasadena	California
United States	Research Site	Sacramento	California
United States	Research Site	Salisbury	North Carolina
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Springfield	Illinois
United States	Research Site	St Louis	Missouri
United States	Research Site	Wellington	Florida
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Colombia,  Costa Rica,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)	Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG 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	No
Secondary	Change in FPG From Baseline to Week 18 (LOCF)	Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG 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	No
Secondary	Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)	Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)	Week 18 (LOCF)	No