N/A
Completed N=3,453
An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)
Source: ClinicalTrials.gov NCT01357135 ↗Enrolled (actual)
3,453
Serious AEs
4.9%
Results posted
Dec 2014
Primary outcomePrimary: Median Duration (in Months) of Initial Dual Therapy — 43.2; 20.2 months
Summary
This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Duration (in Months) of Initial Dual Therapy |
43.2; 20.2 | — |
| PRIMARY Percentage of Participants With Strict Changes in Initial Dual Therapy |
33.1; 46.5 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes participants
- De novo treatment (first prescription or dated within the past 8 weeks) with:
- Metformin + sitagliptin dual therapy,
- Metformin + sulfonylurea dual therapy,
- Sitagliptin as part of another treatment regimen
- Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.
Data sourced from ClinicalTrials.gov (NCT01357135). 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.