A Phase 3 Study of BMS-477118 in Combination With Metformin 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: Metformin; Drug: Saxagliptin; Drug: pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327015

CV181-039

Details and patient eligibility

About

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

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 pioglitazone (rescue medication) added onto their blinded study medication

Enrollment: 1,306 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Inadequate blood sugar control
• No current treatment with other medications to lower blood sugar

Exclusion criteria

• Major heart, liver or kidney problems
• Pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,306 participants in 4 patient groups

Saxagliptin and Metformin (A)

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Saxagliptin

Drug: pioglitazone

Drug: Saxagliptin

Saxagliptin and Metformin (B)

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Saxagliptin

Drug: pioglitazone

Drug: Saxagliptin

Saxagliptin and Placebo (C)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Saxagliptin

Drug: pioglitazone

Drug: Saxagliptin

Metformin and Placebo (D)

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Placebo

Drug: pioglitazone