Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes (PROMPT)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006590

D1680L00003

Details and patient eligibility

About

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent
• Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
• HbA1c ≥7.0% and ≤10.0%

Exclusion criteria

• Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
• Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
• 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: Triple Blind

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286 participants in 2 patient groups

1

Experimental group

Description:

Saxagliptin 5 mg

Treatment:

Drug: Saxagliptin

2

Active Comparator group

Description:

Metformin 500 -1000 mg

Treatment:

Drug: Metformin