Status:
COMPLETED
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 treat...
Detailed Description
This was a multi-center, double-blind, placebo-controlled, 2-arm, parallel group study with a run-in period and up to 5 years treatment period. Following a screening visit (Visit 1) and a screening pe...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2019
Estimated Enrollment :
2004 Patients enrolled
Trial Details
Trial ID
NCT01528254
Start Date
March 30 2012
End Date
April 4 2019
Last Update
September 24 2020
Active Locations (227)
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1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1056ABJ
2
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425AGC
3
Novartis Investigative Site
San Isidro, Buenos Aires, Argentina, 1642
4
Novartis Investigative Site
CABA, Buenos Aires F.D., Argentina, C1179AAB