Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Saxagliptin

Criteria

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