Phase 4
Completed N=608
ALPHA Sitagliptin Add on to Metformin (0431-103)
Source: ClinicalTrials.gov NCT00833027 ↗Enrolled (actual)
608
Serious AEs
2.8%
Results posted
Sep 2010
Primary outcomePrimary: Change From Baseline in HbA1c at Week 24 — -0.6 Percent — p=<0.001
Summary
Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 24 |
-0.6 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 12 |
-0.6 | — |
Eligibility Criteria
Inclusion Criteria
Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry
Data sourced from ClinicalTrials.gov (NCT00833027). 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.