Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Drug: Placebo; Drug: Saxagliptin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316082

CV181-038

Details and patient eligibility

About

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

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 will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Enrollment: 365 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Inadequate blood sugar control

Exclusion criteria

• Previous treatment for diabetes
• Current treatment with other medications to lower blood sugar
• Major heart, liver or kidney problems
• Women who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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365 participants in 5 patient groups, including a placebo group

Saxagliptin 2.5 mg QAM (A)

Experimental group

Description:

PLUS open-label metformin (as needed as rescue medication)

Treatment:

Drug: metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 2.5 mg titrated to 5 mg QAM (B)

Experimental group

Description:

PLUS open-label metformin (as needed as rescue medication)

Treatment:

Drug: metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 5 mg QAM (C)

Experimental group

Description:

PLUS open-label metformin (as needed as rescue medication)

Treatment:

Drug: metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 5 mg QPM (D)

Experimental group

Description:

PLUS open-label metformin (as needed as rescue medication)

Treatment:

Drug: metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Placebo (E)

Placebo Comparator group

Description:

PLUS open-label metformin (as needed as rescue medication)

Treatment:

Drug: metformin

Drug: Placebo