A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin (blinded); Drug: Saxagliptin; Drug: Placebo; Drug: Metformin (open-label)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00374907

CV181-041

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

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 who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Enrollment: 156 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Drug naive
• Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
• Fasting C-peptide ≥1.0 ng/mL
• Body mass index ≤40 kg/m²

Exclusion criteria

• Recent cardiac or cerebrovascular event
• Elevated serum creatinine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

Saxagliptin (A)

Experimental group

Description:

Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Treatment:

Drug: Saxagliptin

Placebo (ST) / Metformin (LT) (B)

Placebo Comparator group

Description:

Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (blinded)

Drug: Placebo