Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00120536
• Collaborator: (none)
• Enrollment: 288
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 22.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the long term 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 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: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

3. Patients with endpoint HbA1c < 7% after 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:

• Not currently on drug therapy for type 2 diabetes

• Blood glucose criteria must be met

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

Exclusion Criteria:

• History of type 1 diabetes

• Evidence of significant diabetic complications

• Serious cardiovascular events within the past 6 months

• 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

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00120536
• Other Study ID Numbers: CLAF237A2384
• First Posted: Jul 18, 2005
• Last Update Posted: May 18, 2017
• Last Verified: May 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 May 18, 2017