- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102388
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
November 16, 2016 updated by: Novartis Pharmaceuticals
This study is not being conducted in the United States.
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1092
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Investigative Centers, Germany
- Novartis Investigative Site
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Basel, Switzerland
- Novartis Pharmaceuticals
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Exclusion Criteria:
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant diabetic complications
- Evidence of serious cardiovascular conditions
- Laboratory value abnormalities as defined by the protocol
- 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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: vildagliptin
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Active Comparator: Gliclazide
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in HbA1c at 104 weeks
Time Frame: 104 weeks
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104 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event profile at 104 weeks
Time Frame: 104 weeks
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104 weeks
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Change from baseline in fasting plasma glucose at 104 weeks
Time Frame: 104 weeks
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104 weeks
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Patients with endpoint HbA1c <7% after 104 weeks
Time Frame: 104 weeks
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104 weeks
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Patients with reduction in HbA1c >/= 0.7% after 104 weeks
Time Frame: 104 weeks
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104 weeks
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Patients with reduction in HbA1x >/= 0.5% after 104 weeks
Time Frame: 104 weeks
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104 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.
- Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24. Erratum In: Horm Metab Res. 2009 Dec;41(12):909.
- Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19.
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
January 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
January 29, 2005
First Submitted That Met QC Criteria
January 28, 2005
First Posted (Estimate)
January 31, 2005
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
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
- Gliclazide
- Vildagliptin
Other Study ID Numbers
- CLAF237A2310
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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