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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Saxagliptin

Criteria

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