Phase 3
Completed N=641
Sitagliptin Added-on to Insulin Study (0431-051)
Source: ClinicalTrials.gov NCT00395343 ↗Enrolled (actual)
641
Serious AEs
4.8%
Results posted
Oct 2009
Primary outcomePrimary: Change From Baseline in A1C at Week 24 — -0.59; -0.03 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 insulin or insulin/metformin combination therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at Week 24 |
-0.61; -0.04 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-18.5; -3.5 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 |
-30.9; 5.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24 |
28.4; -8.1 | 0.01 sig |
| SECONDARY Percent of Patients With A1C < 7.0% at Week 24 |
12.8; 5.1 | <0.001 sig |
| SECONDARY Percent of Patients With A1C < 6.5% at Week 24 |
2.3; 1.9 | 0.584 |
Eligibility Criteria
Inclusion Criteria
- Patient has type 2 diabetes mellitus
- Patient is poorly controlled while on insulin or insulin and metformin
Exclusion Criteria
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient is taking oral antidiabetic agents other than metformin during the past 3 months
- Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin
Data sourced from ClinicalTrials.gov (NCT00395343). 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.