Phase 3
Completed N=30
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Source: ClinicalTrials.gov NCT01034111 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment — 5; 5; 0; 0 Participants
Summary
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment |
5; 5; 0; 0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 4 |
1.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with T2DM failing metformin monotherapy
- Between the ages of 18 and 79
Exclusion Criteria
- Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
Data sourced from ClinicalTrials.gov (NCT01034111). 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.