Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
1 other identifier
interventional
1,179
2 countries
2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Sep 2006
Typical duration for phase_3 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2008
CompletedDecember 19, 2020
May 1, 2017
1.8 years
September 26, 2006
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
At week 24
Secondary Outcomes (5)
Change from baseline in fasting plasma glucose
At week 24
Percent of patients with endpoint HbA1c <7%
At week 24
Percent of patients with reduction in HbA1c >/=0.7%
At week 24
Adverse event profile after treatment
At week 24
Change from baseline in body weight
At week 24
Study Arms (4)
Vildagliptin + Metformin Dose 1
EXPERIMENTALVildagliptin + Metformin Dose 2
EXPERIMENTALVildagliptin
ACTIVE COMPARATORMetformin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of T2DM for at least 4 weeks prior to study entry
- Age 18 - 78 years inclusive
- Body mass index (BMI) of 22 - 40 kg/m2
- HbA1c: 7.5 - 11% inclusive
- FPG \<270 mg/dL (15 mmol/L)
You may not qualify if:
- Pregnant or lactating female
- A history of type 1 diabetes
- Evidence of significant diabetic complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Unknown Facility
Multiple Locations, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 28, 2006
Study Start
September 1, 2006
Primary Completion
June 3, 2008
Study Completion
June 3, 2008
Last Updated
December 19, 2020
Record last verified: 2017-05