Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–78
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
