Phase 3
Completed N=568
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Source: ClinicalTrials.gov NCT00698932 ↗Enrolled (actual)
568
Serious AEs
2.1%
Results posted
Sep 2011
Primary outcomePrimary: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) — 8.15; 8.14; 7.25; 7.75 percent — p=<0.0001
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) |
8.15; 8.14; 7.25; 7.75; -0.84; -0.34 | <0.0001 sig |
| SECONDARY Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) |
9.15; 9.05; 8.10; 8.77; -0.90; -0.17 | <0.0001 sig |
| SECONDARY Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) |
164.85; 163.03; 145.97; 158.04; -16.13; -3.01 | <0.0001 sig |
| SECONDARY Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants |
2474; 2506; 2063; 2262; -417; -235 | 0.001 sig |
| SECONDARY Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants |
44586; 45146; 37166; 40751; -7534; -4255 | 0.001 sig |
| SECONDARY Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24 |
45.8; 28.8 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Type 2 diabetes
- Patients should be drug naïve ie, not received medical treatment for diabetes,
- HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
Exclusion Criteria
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
- Type 1 diabetes, history of ketoacidosis or hyperosmolar non-ketonic koma
Data sourced from ClinicalTrials.gov (NCT00698932). 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.