N/A
Completed N=4,065
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
Source: ClinicalTrials.gov NCT01065766 ↗Enrolled (actual)
4,065
Serious AEs
0.4%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Participants With Any Adverse Experience — 3.74 Percentage of participants
Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Experience |
3.74 | — |
| PRIMARY Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12 |
-0.93 | — |
| PRIMARY Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12 |
-28.21 | — |
| PRIMARY Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12 |
-58.02 | — |
| PRIMARY Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12 |
78.68; 16.38; 4.94 | — |
| PRIMARY Change From Baseline to Treatment in HbA1c at Week 24 |
-1.08 | — |
| PRIMARY Change From Baseline to Treatment in FPG at Week 24 |
-32.40 | — |
| PRIMARY Change From Baseline in 2hr-PPG at Week 24 |
-62.13 | — |
| PRIMARY Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24 |
76.38; 15.88; 7.75 | — |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
- Is treated with sitagliptin/metformin within local label for the first time
Exclusion Criteria
- Has a contraindication to sitagliptin/metformin according to the local label
- Is treated with sitagliptin/metformin before contract and out of enrollment period
Data sourced from ClinicalTrials.gov (NCT01065766). 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.