Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone
A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
1 other identifier
interventional
2,665
1 country
1
Brief Summary
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
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
1 active site
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
October 1, 2007
CompletedNovember 18, 2016
November 1, 2016
1 year
November 2, 2006
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HemoglobinA1c (HbA1c)
after 12 weeks of treatment
Secondary Outcomes (3)
Change from baseline in body weight
after 12 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)
after 12 weeks of treatment
Incidence of prespecified adverse events while on treatment with study drug
12 week treatment duration
Study Arms (2)
1
EXPERIMENTALVildagliptin 100mg + Met
TZD
ACTIVE COMPARATORTZD + metformin
Interventions
TZD add-on to metformin
Eligibility Criteria
You may qualify if:
- Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
- Agreement to maintain the same dose of metformin from screening to the end of the study
- Age in the range of 18-80 years
- Body mass index (BMI) in the range of 22-40 kg/m2
- HbA1c in the range of 7.0 to 10%
- FPG \<270 mg/dL (15 mmol/L)
You may not qualify if:
- A history of type 1 diabetes
- Liver disease
- Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (1)
Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a primary care, type 2 diabetes study. Diabetes Obes Metab. 2009 Oct;11(10):978-86. doi: 10.1111/j.1463-1326.2009.01080.x. Epub 2009 Jul 13.
PMID: 19614942RESULT
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
- NONE
- 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
October 1, 2007
Last Updated
November 18, 2016
Record last verified: 2016-11