|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00300287 |
|
Date of registration:
|
06/03/2006 |
|
Primary sponsor: |
|
|
Public 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
|
|
Scientific 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 |
|
Date of first enrolment:
|
February 2006 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00300287 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion 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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Type 2
|
|
Intervention(s)
|
|
Drug: Vildagliptin
|
|
Primary Outcome(s)
|
|
Change from baseline in HbA1c at 108 weeks
|
|
Secondary Outcome(s)
|
|
Adverse event profile after 108 weeks of treatment
|
|
Change from baseline in body weight at week 108
|
|
Change from baseline in fasting plasma glucose at week 108
|
|
Change in fasting plasma glucose from week 52 to week 108
|
|
Change in HbA1c from week 52 to week 108
|
|
Secondary ID(s)
|
|
CLAF237A2307E1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|