Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00757588

Run by

AstraZeneca

People needed

455

Starts

2008-11-01

Expected to finish

2010-04-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Local Institution — Pune, India
• Local Institution — Pune, India
• Local Institution — Vellore, India
• Local Institution — Aguascalientes, Aguascalientes, Mexico
• Local Institution — Aguascalientes, Aguascalientes, Mexico
• Local Institution — Zapopan, Jal., Jalisco, Mexico
• Local Institution — Mexico City, Mexico City, Mexico
• Local Institution — Mexico City, Mexico City, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Monterrrey, Nuevo León, Mexico
• Local Institution — Veracruz, Veracruz, Mexico
• Local Institution — Elblag, Poland
• Local Institution — Gdansk, Poland
• Local Institution — Krakow, Poland
• Local Institution — Lodz, Poland
• Local Institution — Lublin, Poland
• Local Institution — Sopot, Poland
• Local Institution — Szczecin, Poland
• Local Institution — Wroclaw, Poland
• Local Institution — Zabrze, Poland
• Local Institution — Kursk, Russia
• Local Institution — Saint Petersburg, Russia
• Local Institution — Pune, India

Full record on ClinicalTrials.gov

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