Phase 4
Completed N=40
Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Source: ClinicalTrials.gov NCT01582243 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Nov 2016
Primary outcomePrimary: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 — -0.82 percentage
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 |
-0.82 | — |
| SECONDARY Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 |
-0.82 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 |
-20.6; -19.9 | — |
| SECONDARY Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 |
-40.9; -38.3 | — |
| SECONDARY Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week |
-12.8 | — |
| SECONDARY The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment |
64.1; 66.7; 92.3; 87.2 | — |
Eligibility Criteria
Inclusion criteria
- Outpatients who were 20 years of age and older with diagnosis of T2DM.
- Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
- Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
- Understood the nature of the study, and had signed informed consent form.
Exclusion criteria
- Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
- Patients with renal dysfunction defined as creatinine clearance 3 ULN at Visit 1.
- Female patients who needed to lactate during the study.
Data sourced from ClinicalTrials.gov (NCT01582243). 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.