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

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Treatments

Drug: Saxagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01608724

D1680L00008

Details and patient eligibility

About

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

Full description

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

Enrollment

2,165 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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