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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo matching Metformin; Drug: Placebo matching Saxagliptin; Drug: Saxagliptin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00121641

CV181-011

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently 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 added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Enrollment: 1,035 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Drug naive
• Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
• Fasting C-peptide >= 1 ng/mL
• Body mass index <= 40 kg/m2

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 Women of Child Bearing Potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,035 participants in 5 patient groups, including a placebo group

Saxagliptin 2.5 mg (A)

Experimental group

Description:

Metformin 500-2000 mg (as needed for rescue)

Treatment:

Drug: Placebo matching Metformin

Drug: Metformin

Drug: Metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 5 mg (B)

Experimental group

Description:

Metformin 500-2000 mg (as needed for rescue)

Treatment:

Drug: Placebo matching Metformin

Drug: Metformin

Drug: Metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Saxagliptin 10 mg (C)

Experimental group

Description:

Metformin 500-2000 mg (as needed for rescue)

Treatment:

Drug: Placebo matching Metformin

Drug: Metformin

Drug: Metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Placebo (D)

Placebo Comparator group

Description:

Metformin 500-2000 mg (as needed for rescue)

Treatment:

Drug: Metformin

Drug: Placebo matching Saxagliptin

Drug: Metformin

Open-Label Treatment Cohort (Direct Enrollees) (E)

Experimental group

Description:

Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin

Drug: Saxagliptin