Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
1 other identifier
interventional
179
2 countries
2
Brief Summary
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jan 2005
Shorter than P25 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 27, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedNovember 18, 2016
November 1, 2016
1 year
August 27, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of vildagliptin in combination with insulin during 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks
Secondary Outcomes (5)
Change in HbA1c between 24 weeks and 52 weeks
Change in fasting plasma glucose between 24 weeks and 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Change from baseline in mean daily insulin dose at 52 weeks
Change from baseline in mean daily number of insulin injections at 52 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Only patients successfully completing study CLAF237A2311 are eligible
- Written informed consent
- Ability to comply with all study requirements
You may not qualify if:
- Premature discontinuation from CLAF237A2311
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Novartis Investigative Site
Investigative Centers, Germany
Related Publications (1)
Fonseca V, Baron M, Shao Q, Dejager S. Sustained efficacy and reduced hypoglycemia during one year of treatment with vildagliptin added to insulin in patients with type 2 diabetes mellitus. Horm Metab Res. 2008 Jun;40(6):427-30. doi: 10.1055/s-2008-1058090. Epub 2008 Mar 11. No abstract available.
PMID: 18401832RESULT
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2005
First Posted
August 30, 2005
Study Start
January 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11