Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Saxagliptin + Metformin; Drug: Placebo + Metformin; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00121667

CV181-014

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with 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 pioglitizone added onto their blinded study medication

Enrollment: 1,462 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
• HbA1c >= 7.0% and <= 10.0 %
• Body mass index <= 40 kg/m2
• Fasting C-peptide >= 1 ng/dL

Exclusion criteria

• Symptomatic poorly controlled diabetes
• Recent cardiac or cerebrovascular event
• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,462 participants in 4 patient groups, including a placebo group

Saxagliptin + Metformin (A)

Experimental group

Description:

Pioglitazone 15-45 mg (as needed for rescue)

Treatment:

Drug: Saxagliptin + Metformin

Drug: Saxagliptin + Metformin

Drug: Pioglitazone

Drug: Saxagliptin + Metformin

Saxagliptin + Metformin (B)

Experimental group

Description:

Pioglitazone 15-45 mg (as needed for rescue)

Treatment:

Drug: Saxagliptin + Metformin

Drug: Saxagliptin + Metformin

Drug: Pioglitazone

Drug: Saxagliptin + Metformin

Saxagliptin + Metformin (C)

Experimental group

Description:

Pioglitazone 15-45 mg (as needed for rescue)

Treatment:

Drug: Saxagliptin + Metformin

Drug: Saxagliptin + Metformin

Drug: Pioglitazone

Drug: Saxagliptin + Metformin

Placebo+ Metformin (D)

Placebo Comparator group

Description:

Pioglitazone 15-45 mg (as needed for rescue)

Treatment:

Drug: Pioglitazone

Drug: Placebo + Metformin