Phase 4
Completed N=228
Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01882907 ↗Enrolled (actual)
228
Serious AEs
2.6%
Results posted
Mar 2015
Primary outcomePrimary: Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group — -0.94; -0.60 % (change of HbA1c)
Summary
The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group |
-0.94; -0.60 | — |
| SECONDARY the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups |
-20.41; -15.04; -60.23; -38.19 | — |
| SECONDARY the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups |
-9.22; -4.79; -6.45; 9.60; -6.03; 5.38 | — |
| SECONDARY the Mean Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups |
-0.07; 0.69 | — |
| SECONDARY the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups |
0.36; -8.21; 0.07; -0.24; -0.06; -3.33 | — |
Eligibility Criteria
Inclusion Criteria
- Age in the range of 18 to 80 years
- HbA1c 7 to 11%
- FPG 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
- Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1
- Any of the following laboratory abnormalities
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the normal range at visit 1
- Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1
- Serum creatinine levels > 2.5 mg/dL (220 μmol/L) at visit 1
- Clinically significant thyroid-stimulating hormone (TSH) outside normal range at visit 1
Data sourced from ClinicalTrials.gov (NCT01882907). 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.