Phase 4
Completed N=40
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Source: ClinicalTrials.gov NCT02007278 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jul 2017
Primary outcomePrimary: Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) — 6.68; 6.23 mg/dL — p=0.4510
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) |
6.68; 6.23 | 0.4510 |
| SECONDARY Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) |
2.92; 3.01 | — |
| SECONDARY Glycemic Variability Measured by Total Standard Deviation (TSD) |
1.36; 1.40 | — |
| SECONDARY Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12 |
100.0; 100.0 | — |
| SECONDARY Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline |
1.92; 2.28 | — |
| SECONDARY Number of Patients With Incidence of Hypoglycemia |
1; 4 | — |
| SECONDARY Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment |
5.23; 5.53 | — |
| SECONDARY Number of Patients With Any Adverse Events, Serious Adverse Events and Death |
9; 13; 0; 1; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1
Key Exclusion Criteria
- Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin
Data sourced from ClinicalTrials.gov (NCT02007278). 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.