Phase 3
Completed N=262
Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
Source: ClinicalTrials.gov NCT00350779 ↗Enrolled (actual)
262
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18 — -1.03; -0.31 Percent — p=<0.001
Summary
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18 |
-1.03; -0.31 | <0.001 sig |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18 |
-30.7; -11.7 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18 |
-59.9; -22.0 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 |
-1.05; -0.28 | <0.001 sig |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 |
-28.0; -10.7 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54 |
-50.7; -16.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has type 2 diabetes mellitus
- Patient is inadequately controlled while taking two oral antidiabetic medications
Exclusion Criteria
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient required insulin therapy within the prior 3 months
- Patient has been taking Byetta (R) (exenatide) within the prior 3 months
Data sourced from ClinicalTrials.gov (NCT00350779). 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.