Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy
1 other identifier
interventional
914
2 countries
2
Brief Summary
This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid 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
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 2, 2006
CompletedFirst Posted
Study publicly available on registry
November 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedDecember 17, 2020
December 1, 2012
1.7 years
November 2, 2006
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
24 weeks
Secondary Outcomes (5)
Adverse event profile after 24 weeks of treatment
24 weeks
Gastrointestinal tolerability after 24 weeks of treatment
24 weeks
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks
24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks
24 weeks
Change from baseline in fasting plasma glucose after 24 weeks
24 weeks
Study Arms (2)
vildagliptin + metformin
EXPERIMENTALMetformin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years inclusive
- Type 2 diabetes diagnosis at least 2 months prior to study entry
- Body mass index in the range of 22-45 kg/m2
- HbA1c in the range of 6.5 to 9% inclusive
- Fasting plasma glucose \<270 mg/dL (15 mmol/L)
You may not qualify if:
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- Congestive heart failure requiring pharmacologic treatment
- Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Novartis Investigative Site
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 2006
First Posted
November 6, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2008
Last Updated
December 17, 2020
Record last verified: 2012-12