Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00138541
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 24.5

Study Details

Study Description

Brief Summary

This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. Safety of vildagliptin during 52 weeks of treatment []

2. Change from baseline in HbA1c at 52 weeks []

Secondary Outcome Measures

1. Change in HbA1c between 24 weeks and 52 weeks []

2. Change from baseline in fasting plasma glucose at 52 weeks []

3. Change in fasting plasma glucose between 24 weeks and 52 weeks []

4. Change from baseline in HOMA B at 52 weeks []

5. Change from baseline in HOMA IR at 52 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Only patients successfully completing study CLAF237A2301 are eligible

• Written informed consent

• Ability to comply with all study requirements

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2301

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States	07936

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00138541
• Other Study ID Numbers: CLAF237A2301E1
• First Posted: Aug 30, 2005
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: type 2 diabetes; vildagliptin
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vildagliptin

Study Results

No Results Posted as of Mar 1, 2017