Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00099918
• Collaborator: (none)
• Enrollment: 717
• Locations: 2
• Duration (Months): 16
• Patients Per Site: 358.5
• Patients Per Site Per Month: 22.4

Study Details

Study Description

Brief Summary

The purpose of this study is 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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 717 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive 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 at 24 weeks []

Secondary Outcome Measures

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

2. Adverse event profile after 24 weeks of treatment []

3. Patients with endpoint HbA1c <7% at 24 weeks []

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

5. Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Blood glucose criteria must be met

• Not currently on drug therapy for type 2 diabetes

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

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of serious diabetic complications

• Evidence of serious cardiovascular conditions

• 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
2	Novartis Investigative Sites	Investigative Centers		Germany

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: NCT00099918
• Other Study ID Numbers: CLAF237A2327
• First Posted: Dec 22, 2004
• Last Update Posted: May 17, 2017
• Last Verified: May 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 May 17, 2017