Phase 3
Completed N=282
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00960076 ↗Enrolled (actual)
282
Serious AEs
1.1%
Results posted
Sep 2011
Primary outcomePrimary: Change in HbA1c Level From Baseline to Week 18 (LOCF) — 8.41; 8.28; 7.53; 7.93 Percent
Summary
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c Level From Baseline to Week 18 (LOCF) |
8.41; 8.28; 7.53; 7.93; -0.88; -0.35 | — |
| SECONDARY Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF) |
227.36; 223.68; 195.11; 216.24; -31.52; -8.20 | — |
| SECONDARY Change in FPG From Baseline to Week 18 (LOCF) |
162.54; 163.35; 142.70; 156.32; -20.03; -6.85 | — |
| SECONDARY Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1) |
37.2; 26.1 | 0.0459 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
- A1c: 7.5-11% (at screening)
- BMI less than or equal to 45 kg/m2
Exclusion Criteria
- Significant cardiovascular history
- Active liver disease, renal impairment
Data sourced from ClinicalTrials.gov (NCT00960076). 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.