Status:
COMPLETED
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT00757588
Start Date
November 1 2008
End Date
April 1 2010
Last Update
June 1 2015
Active Locations (80)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Advantage, Inc
Tempe, Arizona, United States, 85282
2
Valley Research
Fresno, California, United States, 93720
3
Torrance-Lomita Medical Center
Lomita, California, United States, 90717
4
Diabetes Medical Center Of California
Northridge, California, United States, 91325