A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Drug: Metformin; Drug: Glyburide; Drug: Saxagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313313

CV181-040

Details and patient eligibility

About

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Full description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Enrollment: 768 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 2 Diabetes.
• Treated with a sulfonylurea for at least 2 months.
• Inadequate blood sugar control.
• Are not on any other medications to lower blood sugar.
• No major heart, liver or kidney problems.
• Women not pregnant or breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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768 participants in 3 patient groups, including a placebo group

Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)

Experimental group

Description:

Metformin 500-2500 mg (as needed)

Treatment:

Drug: Metformin

Drug: Glyburide

Drug: Glyburide

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 5 mg + Glyburide 7.5 mg (B)

Experimental group

Description:

Metformin 500-2500 mg (as needed)

Treatment:

Drug: Metformin

Drug: Glyburide

Drug: Glyburide

Drug: Saxagliptin

Drug: Saxagliptin

Placebo + Glyburide 7.5 mg (C)

Placebo Comparator group

Description:

Metformin 500-2500 mg (as needed)

Treatment:

Drug: Metformin

Drug: Glyburide

Drug: Glyburide

Drug: Placebo