Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00138619 |
Recruitment Status
:
Completed
First Posted
: August 30, 2005
Last Update Posted
: May 7, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: vildagliptin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 478 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

- Safety during 104 weeks of treatment
- Change from baseline in HbA1c at 104 weeks
- Change in HbA1c between 24 weeks and 104 weeks
- Change from baseline in fasting plasma glucose at 104 weeks
- Change in fasting plasma glucose between 24 weeks and 104 weeks
- Change from baseline in HOMA B at 104 weeks
- Change in HOMA B between 24 weeks and 104 weeks

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Only patients successfully completing study CLAF237A2327 are eligible
- Written informed consent
- Ability to comply with all study requirements
Exclusion Criteria:
- Premature discontinuation from study CLAF237A2327
- Other protocol-defined exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138619
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 | |
Germany | |
Investigative Centers, Germany |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00138619 History of Changes |
Other Study ID Numbers: |
CLAF237A2327E1 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | May 7, 2012 |
Last Verified: | May 2012 |
Keywords provided by Novartis:
Type 2 diabetes vildagliptin |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Rosiglitazone Vildagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |