Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00099892
• Collaborator: (none)
• Enrollment: 544
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 33.9

Study Details

Study Description

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 544 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. Change from baseline in HbA1c after 24 weeks []

Secondary Outcome Measures

1. Change from baseline in fasting plasma glucose at 24 weeks []

2. Patients with endpoint HbA1c <7% after 24 weeks []

3. Patients with reduction in HbA1c >/=to 0.7% after 24 weeks []

4. Change from baseline in body weight at 24 weeks []

5. Change from baseline in fasting lipids at 24 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Blood glucose criteria must be met

• On a stable dose of metformin as defined by the protocol

• Body mass index (BMI) in the range 22-45

Exclusion Criteria:

• Type 1 diabetes

• Pregnancy or lactation

• Evidence of serious diabetic complications

• Evidence of serious cardiovascular complications

• Laboratory value abnormalities as defined by the protocol

• 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 Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00099892
• Other Study ID Numbers: CLAF237A2303
• First Posted: Dec 22, 2004
• Last Update Posted: Aug 2, 2017
• Last Verified: Jul 1, 2017

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

Study Results

No Results Posted as of Aug 2, 2017