52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Saxagliptin; Drug: Sulphonylurea

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575588

EudraCT number 2007-003998-55

D1680C00001

Details and patient eligibility

About

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 sulphonylurea in addition with metformin.

Enrollment: 891 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 prior to Visit 1,
• HbA1c >6.5% and ≤10.0%

Exclusion criteria

• Type 1 diabetes,
• history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
• Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

891 participants in 2 patient groups

Saxagliptin

Experimental group

Treatment:

Drug: Saxagliptin

Drug: Metformin

Glipizide

Experimental group

Treatment:

Drug: Sulphonylurea

Drug: Metformin