Phase 3
Completed N=337
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Source: ClinicalTrials.gov NCT01545388 ↗Enrolled (actual)
337
Serious AEs
1.8%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) — -0.434; -0.587; 0.091 Percent of glycosylated hemoglobin — p=<0.001
Summary
This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) |
-0.434; -0.587; 0.091 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event |
65.9; 67.7; 60.6 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
2; 3; 1 | — |
| SECONDARY Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) |
-9.02; -11.27; 7.32 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes Mellitus (T2DM)
- Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
- Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and < 10.0%
Exclusion Criteria
- Type 1 diabetes mellitus,
- Secondary diabetes mellitus, or
- Gestational diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT01545388). 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.