Phase 3
Completed N=1,050
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
Source: ClinicalTrials.gov NCT00449930 ↗Enrolled (actual)
1,050
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 — -0.43; -0.57 Percent
Summary
A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 |
-0.43; -0.57 | — |
| SECONDARY Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea |
19; 57; 509; 465 | <0.001 sig |
| SECONDARY Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea |
6; 16; 522; 506 | 0.032 sig |
| SECONDARY Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain |
11; 20; 517; 502 | 0.103 |
| SECONDARY Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting |
2; 7; 526; 515 | — |
Eligibility Criteria
General Inclusion Criteria:
- Patient has type 2 diabetes mellitus (T2DM)
- Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy
General Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
Data sourced from ClinicalTrials.gov (NCT00449930). 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.