Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101673
• Other study ID #: CLAF237A2329
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2005
• Last updated: May 4, 2012
• Start date: March 2004
• Est. completion date: June 2005

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was not conducted in the United States. The purpose of this study was 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• vildagliptin

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at 12 weeks
Secondary	Adverse event profile after 12 weeks of treatment
Secondary	Patients with reduction in HbA1c >/= 0.7% after 12 weeks
Secondary	Change from baseline in fasting plasma glucose at 12 weeks
Secondary	Change from baseline in HOMA-B at 12 weeks
Secondary	Change from baseline in body weight at 12 weeks