Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin, 5 mg + insulin; Drug: Placebo + insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757588

CV181-057

Eudract-2008-001089-10

Details and patient eligibility

About

The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Enrollment: 455 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
• If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
• Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
• Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
• Body mass index of 45 kg/m² or lower
• Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion criteria

• Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Active liver disease
• Anemia
• Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
• Use of short- or rapid-acting insulin
• Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
• Congestive heart failure
• Unstable or rapidly progressing renal disease
• History of alcohol or drug abuse within the previous year
• History of hemoglobinopathies
• Unstable major psychiatric disorders
• Immunocompromised status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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455 participants in 2 patient groups, including a placebo group

Saxagliptin, 5 mg + insulin

Experimental group

Description:

Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Treatment:

Drug: Saxagliptin, 5 mg + insulin

Placebo + insulin

Placebo Comparator group

Description:

Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Treatment:

Drug: Placebo + insulin