Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin, 5 mg + insulin; Placebo + insulin
Intervention description: Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue); Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 455.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

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.
    

Eligibility 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