Overview

Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Treatments:
Glimepiride
Metformin
Saxagliptin
Criteria
Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin
monotherapy, for at least 8 weeks prior to Visit 1

- HbA1c ≥7.0% and ≤9.0%

Exclusion Criteria:

- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
Current use of any injectable or oral antihyperglycemic agent excluding metformin.

- Renal impairment as defined by a creatinine clearance <60 mL/min

- Individuals who, in the opinion of the investigator, in which participation in this
study may pose a significant risk to the patient and could render the patient unable
to successfully complete the study