Phase 3
Completed N=455
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Source: ClinicalTrials.gov NCT00757588 ↗Enrolled (actual)
455
Serious AEs
8.4%
Results posted
Dec 2011
Primary outcomePrimary: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) — -0.73; -0.32 Percentage of change — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) |
-0.73; -0.32 | <0.0001 sig |
| SECONDARY Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT) |
-4548.5; -718.8 | 0.0011 sig |
| SECONDARY Change From Baseline in 120-minute PPG Values During an MTT |
-27.2; -4.2 | 0.0016 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Values |
-10.1; -6.1 | 0.3958 |
| SECONDARY Percentage of Participants Achieving a Therapeutic Glycemic Response |
17.3; 6.7 | — |
| SECONDARY Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF) |
1.71; 5.01 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00757588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.