- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238498
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
April 30, 2012 updated by: Novartis
This study was not conducted in the United States.
The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.
Study Overview
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of type 2 diabetes
- Patients who have been placed on diet and exercise therapy without achievement of glycemic control
- Outpatients
Exclusion Criteria:
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant cardiovascular diseases
- Significant diabetic complications
- Other protocol-defined exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline in HbA1c at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline on fasting plasma glucose at 12 weeks
|
Change from baseline for postprandial glucose at 12 weeks
|
Change from baseline on postprandial glucose AUC at 12 weeks
|
Change from baseline in HOMA B at 12 weeks
|
Change from baseline in HOMA IR at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
October 12, 2005
First Submitted That Met QC Criteria
October 12, 2005
First Posted (Estimate)
October 13, 2005
Study Record Updates
Last Update Posted (Estimate)
May 2, 2012
Last Update Submitted That Met QC Criteria
April 30, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLAF237A1202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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