Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
1 other identifier
interventional
515
1 country
1
Brief Summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started May 2004
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
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 21, 2004
CompletedFirst Posted
Study publicly available on registry
December 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMay 7, 2012
May 1, 2012
1.4 years
December 21, 2004
May 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c after 24 weeks
Secondary Outcomes (5)
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Study Arms (3)
LAF237 50 mg qd + glimepiride 4 mg qd
EXPERIMENTALLAF237 50 mg qd + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd
EXPERIMENTALLAF237 50 mg bid + glimepiride 4 mg qd
LAF237 placebo + glimepiride 4 mg qd
PLACEBO COMPARATORLAF237 placebo + glimepiride 4 mg qd
Interventions
Glimepiride 4 mg qd
Eligibility Criteria
You may qualify if:
- Blood glucose criteria must be met
- Previously treated with a sulfonylurea for at least 3 months
- Body mass index (BMI) in the range 22-45
You may not qualify if:
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic complications
- Laboratory value abnormalities as defined by the protocol
- Known sensitivity to glimepiride
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (1)
Garber AJ, Foley JE, Banerji MA, Ebeling P, Gudbjornsdottir S, Camisasca RP, Couturier A, Baron MA. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18.
PMID: 18284434DERIVED
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2004
First Posted
December 22, 2004
Study Start
May 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
May 7, 2012
Record last verified: 2012-05