Phase 4
Completed N=117
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Source: ClinicalTrials.gov NCT01766778 ↗Enrolled (actual)
117
Serious AEs
3.4%
Results posted
Apr 2017
Primary outcomePrimary: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 — -0.8; -1.0 percentage of Glycosylated Hemoglobin
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 |
-0.8; -1.0 | — |
| SECONDARY Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) |
-0.6; -0.9; -0.7; -0.9; -0.7; -0.7 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) |
-0.9; -1.3; -1.2; -0.9; -1.1; -1.0 | — |
| SECONDARY Percentage of Patients Achieving Good Glycemic Control |
33.3; 47.5; 39.2; 45.6; 45.1; 47.4 | — |
| SECONDARY Percentage of Overall Drug Compliance in 12 Months |
96.90; 97.48 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability |
15; 14; 2; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female in age ≥18 at Visit 1
- Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
- HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
- With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin
Key Exclusion Criteria
- Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
- Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
- Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
- Pregnant women or breastfeeding women at the time of enrolment
- Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
Data sourced from ClinicalTrials.gov (NCT01766778). 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.