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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102388
• Other study ID #: CLAF237A2310
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2005
• Last updated: November 16, 2016
• Start date: January 2005

Study information

• Verified date: November 2016
• 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 is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1092
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not currently on drug therapy for type 2 diabetes

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

• Blood glucose criteria must be met

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of significant 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 (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• vildagliptin

• Gliclazide

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Investigative Centers
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (3)

Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19. — View Citation

Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naïve patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s- — View Citation

Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at 104 weeks		104 weeks	No
Secondary	Adverse event profile at 104 weeks		104 weeks	Yes
Secondary	Change from baseline in fasting plasma glucose at 104 weeks		104 weeks	No
Secondary	Patients with endpoint HbA1c <7% after 104 weeks		104 weeks	No
Secondary	Patients with reduction in HbA1c >/= 0.7% after 104 weeks		104 weeks	No
Secondary	Patients with reduction in HbA1x >/= 0.5% after 104 weeks		104 weeks	No

External Links

•   Results for CLAF237A2310 from the Novartis Clinical Trials Website