Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00138593
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. 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.

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

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. Safety in combination with pioglitizone after 52 weeks of treatment []

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

Secondary Outcome Measures

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

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

3. Change from baseline in body weight at 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 and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Only patients successfully completing study CLAF237A2329 are eligible

• Written informed consent

• HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units

• Ability to comply with all study requirements

Exclusion Criteria:

• Premature discontinuation from study CLAF237A2329

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	Basel		Switzerland

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: NCT00138593
• Other Study ID Numbers: CLAF237A2329E1
• 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