Back to resultsA 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
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, Vildagliptin
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Premature discontinuation from study CLAF237A2307
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c at 108 weeks
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00300287
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 20, 2006 (Actual)
Primary Completion Date
June 26, 2007 (Actual)
Study Completion Date
June 26, 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes, Vildagliptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at 108 weeks
Secondary Outcome Measure Information:
Title
Adverse event profile after 108 weeks of treatment
Title
Change in HbA1c from week 52 to week 108
Title
Change from baseline in fasting plasma glucose at week 108
Title
Change in fasting plasma glucose from week 52 to week 108
Title
Change from baseline in body weight at week 108
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Premature discontinuation from study CLAF237A2307
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Investigative Sites
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18355325
Citation
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.
Results Reference
derived
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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
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