Expired Study
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Lomita, California 90717


Purpose:

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.


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


NCT ID:

NCT00757588


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Lomita, California 90717
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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