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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glimepiride; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006603

D1680L00002

Details and patient eligibility

About

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.

Enrollment: 957 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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957 participants in 2 patient groups

1

Experimental group

Description:

Saxagliptin 5 mg

Treatment:

Drug: Saxagliptin

2

Active Comparator group

Description:

Glimepiride 1 - 6 mg

Treatment:

Drug: Glimepiride