The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus

A Multicenter, Single Arm, Cohort Study to Evaluate the Efficacy and Safety of Saxagliptin 5mg, Once Daily for 24 Weeks, in Patients With Type 2 Diabetes Mellitus

The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
• Men or women who are >18 years of age at time of consenting upon Visit 1
• HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
• Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)

Exclusion Criteria:

• Pregnant or breastfeeding patients
• Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
• Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
• History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
• Treatment with systemic glucocorticoids other than replacement therapy
• Inhaled, local injected and topical use of glucocorticoids is allowed