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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin; Drug: Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960076

D1680L00005

Details and patient eligibility

About

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

Enrollment: 282 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 2 patient groups

1

Experimental group

Description:

Saxagliptin

Treatment:

Drug: Saxagliptin

Drug: Metformin XR

Drug: Metformin XR

2

Active Comparator group

Description:

Metformin Extended Release

Treatment:

Drug: Metformin XR

Drug: Metformin XR