Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Saxagliptin, 5 mg + insulinDrug: Placebo + insulin
- Registration Number
- NCT00757588
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 455
- 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/mยฒ or lower
- Fasting C-peptide level of 0.8 ng/mL or higher
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saxagliptin, 5 mg + insulin Saxagliptin, 5 mg + insulin Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin Placebo + insulin Placebo + insulin Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) Baseline to Week 24 Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF) Baseline to Week 24 Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.
Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT) Baseline to Week 24 An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal
Change From Baseline in 120-minute PPG Values During an MTT Baseline to Week 24 An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.
Change From Baseline in Fasting Plasma Glucose Values Baseline to Week 24 Percentage of Participants Achieving a Therapeutic Glycemic Response Baseline to Week 24 Therapeutic glycemic response is defined as an A1C\<7%. Significance was not interpreted with a p value.
Trial Locations
- Locations (17)
Clinical Research Advantage, Inc
๐บ๐ธTempe, Arizona, United States
Southgate Medical Group
๐บ๐ธWest Seneca, New York, United States
Valley Research
๐บ๐ธFresno, California, United States
Torrance-Lomita Medical Center
๐บ๐ธLomita, California, United States
Family Care Associates Of Nw Florida
๐บ๐ธChipley, Florida, United States
Diabetes Medical Center Of California
๐บ๐ธNorthridge, California, United States
Central Florida Clinical Trials, Inc.
๐บ๐ธAltamonte Springs, Florida, United States
Encompass Clinical Research
๐บ๐ธSpring Valley, California, United States
Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.
๐บ๐ธMarianna, Florida, United States
Endocrine Research Solutions, Inc.
๐บ๐ธRoswell, Georgia, United States
Aurora Advanced Healthcare
๐บ๐ธMilwaukee, Wisconsin, United States
Local Institution
๐ฌ๐งSheffield, Yorkshire, United Kingdom
Ritchken & First M.D.'S
๐บ๐ธSan Diego, California, United States
Texas Center For Drug Development
๐บ๐ธHouston, Texas, United States
Dgd Research, Inc.
๐บ๐ธSan Antonio, Texas, United States
Danny W. Jackson P.A.
๐บ๐ธRolling Fork, Mississippi, United States
Southeastern Research Associates, Inc.
๐บ๐ธTaylors, South Carolina, United States