Phase 3
Completed N=257
Saxagliptin Triple Oral Therapy
Source: ClinicalTrials.gov NCT01128153 ↗Enrolled (actual)
257
Serious AEs
3.9%
Results posted
Aug 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) — -0.74; -0.08 percent — p=<0.0001
Summary
The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) |
-0.74; -0.08 | <0.0001 sig |
| SECONDARY Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] |
-11.66; 5.08 | 0.0301 sig |
| SECONDARY Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] |
-0.65; 0.28 | 0.0301 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] |
-5.28; 2.62 | 0.0868 |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] |
-0.29; 0.15 | 0.0868 |
| SECONDARY Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF) |
39; 12 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Written Informed Consent
- Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and 10% weight loss in 3 months prior to entry, or other signs and symptoms
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
- Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
- Estimated CrCl 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
- Creatine kinase > or = 10 x ULN at Visit 2
Data sourced from ClinicalTrials.gov (NCT01128153). 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.