Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Vildagliptin
A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
2 other identifiers
interventional
317
9 countries
55
Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Oct 2010
Shorter than P25 for phase_3 type-2-diabetes-mellitus
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 23, 2017
February 1, 2017
1.1 years
November 1, 2010
February 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c Reduction
24 weeks
Secondary Outcomes (3)
FPG reduction
24 weeks
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
24 weeks
Responder Rate
24 weeks
Study Arms (2)
Vildagliptin (metformin + glimepiride)
EXPERIMENTALPlacebo (metformin + glimepiride)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of T2DM by standard criteria.
- Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
- Age: ≥18 to ≤ 80 years
- HbA1c of ≥ 7.5 and ≤ 11.0%
- Body Mass Index (BMI) ≥22 to ≤45 kg/m2
You may not qualify if:
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (55)
Novartis Investigative Site
Box Hill, Australia
Novartis Investigative Site
Heidelberg, Australia
Novartis Investigative Site
Parkville, Australia
Novartis Investigative Site
St Leonards, Australia
Novartis Investigative Site
Anderbeck, Germany
Novartis Investigative Site #1
Berlin, Germany
Novartis Investigative Site #2
Berlin, Germany
Novartis Investigative Site #3
Berlin, Germany
Novartis Investigative Site #4
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hildesheim, Germany
Novartis Investigative Site
Sangerhausen, Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Érd, Hungary
Novartis Investigative Site
Törökbálint, Hungary
Novartis Investigative Site
Bergamo, Italy
Novartis Investigative Site
Cosenza, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Padua, Italy
Novartis Investigative Site
Pisa, Italy
Novartis Investigative Site #1
Roma, Italy
Novartis Investigative Site #2
Roma, Italy
Novartis Investigative Site
Torino, Italy
Novartis Investigative Site #1
Aguascalientes, Mexico
Novartis Investigative Site #2
Aguascalientes, Mexico
Novartis Investigative Site #3
Aguascalientes, Mexico
Novartis Investigative Site #1
Durango, Mexico
Novartis Investigative Site #2
Durango, Mexico
Novartis Investigative Site #3
Durango, Mexico
Novartis Investigative Site #1
Guadalajara, Mexico
Novartis Investigative Site #2
Guadalajara, Mexico
Novartis Investigative Site #3
Guadalajara, Mexico
Novartis Investigative Site #4
Guadalajara, Mexico
Novartis Investigative Site #5
Guadalajara, Mexico
Novartis Investigative Site
México, Mexico
Novartis Investigative Site #1
Pachuca, Mexico
Novartis Investigative Site #2
Pachuca, Mexico
Novartis Investigative Site #3
Pachuca, Mexico
Novartis Investigative Site
Manila, Philippines
Novartis Investigative Site #1
Quezon City, Philippines
Novartis Investigative Site #2
Quezon City, Philippines
Novartis Investigative Site
Alba Iulia, Romania
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site #1
Oradea, Romania
Novartis Investigative Site #2
Oradea, Romania
Novartis Investigative Site
Târgu Mureş, Romania
Novartis Investigative Site
Bundang, South Korea
Novartis Investigative Site #1
Seoul, South Korea
Novartis Investigative Site #2
Seoul, South Korea
Novartis Investigative Site #3
Seoul, South Korea
Novartis Investigative Site
Suwon, South Korea
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Yongkang District, Taiwan
Related Publications (1)
Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.
PMID: 24199686RESULT
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
November 1, 2010
First Posted
November 3, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 23, 2017
Record last verified: 2017-02