A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
1 other identifier
interventional
150
1 country
1
Brief Summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Feb 2006
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
February 20, 2006
CompletedFirst Submitted
Initial submission to the registry
March 6, 2006
CompletedFirst Posted
Study publicly available on registry
March 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2007
CompletedAugust 2, 2017
July 1, 2017
1.3 years
March 6, 2006
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 108 weeks
Secondary Outcomes (5)
Adverse event profile after 108 weeks of treatment
Change in HbA1c from week 52 to week 108
Change from baseline in fasting plasma glucose at week 108
Change in fasting plasma glucose from week 52 to week 108
Change from baseline in body weight at week 108
Interventions
Eligibility Criteria
You may qualify if:
- Completion of study CLAF237A2307 within 4 weeks of entering into the extension
- Written informed consent
- Ability to comply with all study requirements
- Blood glucose criteria must be met
You may not qualify if:
- Premature discontinuation from study CLAF237A2307
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Unknown Facility
Investigative Sites, Germany
Related Publications (1)
Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y, Dunning BE, Foley JE. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes Metab. 2008 Nov;10(11):1114-24. doi: 10.1111/j.1463-1326.2008.00875.x. Epub 2008 Mar 18.
PMID: 18355325DERIVED
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
Study Record Dates
First Submitted
March 6, 2006
First Posted
March 8, 2006
Study Start
February 20, 2006
Primary Completion
June 26, 2007
Study Completion
June 26, 2007
Last Updated
August 2, 2017
Record last verified: 2017-07