Phase 4
Completed N=2,001
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01528254 ↗Enrolled (actual)
2,001
Serious AEs
17.5%
Results posted
Apr 2020
Primary outcomePrimary: Time to Initial Treatment Failure — 7.81; 19.97; 17.79; 34.67 Rate (%) — p=<0.001
◆ Published Evidence
Highly cited
352citations · ~50 / year
Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial.
Summary
The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
Linked Publications (5)
-
Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial.
-
Insights from VERIFY: Early Combination Therapy Provides Better Glycaemic Durability Than a Stepwise Approach in Newly Diagnosed Type 2 Diabetes.
-
Baseline characteristics in the VERIFY study: a randomized trial assessing the durability of glycaemic control with early vildagliptin-metformin combination in newly diagnosed Type 2 diabetes.
-
The societal impact of early intensified treatment in patients with type 2 diabetes mellitus.
-
Exploring early combination strategy in Latin American patients with newly diagnosed type 2 diabetes: a sub-analysis of the VERIFY study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Initial Treatment Failure |
7.81; 19.97; 17.79; 34.67; 31.24; 48.31 | <0.001 sig |
| SECONDARY Rate of Loss in Glycemic Control During Period 1 |
0.24; 0.27 | 0.042 sig |
| SECONDARY Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2 |
1.11; 1.02 | 0.635 |
| SECONDARY Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1 |
0.25; 0.26 | 0.530 |
| SECONDARY Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2 |
1.27; 0.99 | 0.381 |
| SECONDARY Rate of Loss of Beta Cell Function From Baseline to End of Study |
-0.60; -0.53; -0.93; -0.43; -1.04; -0.46 | 0.744 |
| SECONDARY Rate of Change in Insulin Sensitivity From Baseline to End of Study |
-4.61; 0.41; -6.07; -0.99; -6.39; -1.01 | 0.020 sig |
| SECONDARY Percentage of Participants With Adverse Events, Serious Adverse Events and Death |
83.5; 83.2; 16.6; 18.3; 1.3; 0.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago
- glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1
- Treatment-naïve.
- Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1
Key Exclusion Criteria
- Pregnant or nursing (lactating) women
- Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)
- Previous or current participation in any vildagliptin clinical study.
- History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.
- Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period.
Data sourced from ClinicalTrials.gov (NCT01528254) and the linked publication. 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.