Phase 3
Completed N=1,132
Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)
Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00545584 ↗
Enrolled (actual)
1,132
Serious AEs
2.9%
Results posted
May 2011
Primary outcomePrimary: Hemoglobin A1c Measurement — 7.37; 7.50; 7.49; 7.33 percent HbA1c
Summary
To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c Measurement |
7.37; 7.50; 7.49; 7.33; 7.42; 7.40 | — |
| SECONDARY Fasting Plasma Glucose (FPG) Measurement |
8.87; 9.00; 8.91; 8.21; 8.32; 8.47 | — |
Eligibility Criteria
Inclusion Criteria
- Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)
Exclusion Criteria
- Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
- Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
- Known hypersensitivity or contraindication to metformin
Data sourced from ClinicalTrials.gov (NCT00545584). 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.