Official Title: “A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to 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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin
  • 5 mg, oral tablet, once daily
• Drug: Glimepiride
  • 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Saxagliptin 5 mg
• Active Comparator: 2
  • Glimepiride 1 - 6 mg

Primary Measures

• The primary endpoint is the proportion of patients reaching HbA1c target <7% without hypoglycaemia over a 52-week treatment period.
  • Time Frame: From week 0 to week 52.
    Safety Issue?: Yes

Secondary Measures

• Proportion of patients having experienced at least one hypoglycaemic event over the 52-week double-blind treatment period.
  • Time Frame: From week 0 to week 52.
    Safety Issue?: Yes
• Change from baseline to week 52 in: HbA1c, fasting plasma glucose, insulin and β-cell function (HOMA-β).
  • Time Frame: From week 0 to week 52.
    Safety Issue?: No
• Safety and tolerability evaluated by assessment of adverse events, laboratory values, electrocardiogram, blood pressure, pulse rate, body weight and physical examination.
  • Time Frame: From week 0 to week 52.
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Overall Contact: AstraZeneca Leif Lohm Nordic Medical Director Cardiovascular +46 8 553 260 00 leif.lohm@astrazeneca.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01006603

Study ID Number: D1680L00002

ClinicalTrials.gov Identifier: NCT01006603

Health Authority: Austria: Agency for Health and Food Safety