Expired Study
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East Hanover, New Jersey 07936


Purpose:

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Criteria:

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


Study is Available At:


Original ID:

CLAF237A2327E1


NCT ID:

NCT00138619


Secondary ID:


Study Acronym:


Brief Title:

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes


Official Title:

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

478


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:November 2004
Completion Date:April 2007
Completion Type:Actual
Primary Completion Date:April 2007
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 4, 2012
First Received Date:August 27, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety during 104 weeks of treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in HbA1c at 104 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in HbA1c between 24 weeks and 104 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in fasting plasma glucose at 104 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in fasting plasma glucose between 24 weeks and 104 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in HOMA B at 104 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in HOMA B between 24 weeks and 104 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:vildagliptin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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