Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396227
• Other study ID #: CLAF237A23119
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: November 16, 2016
• Start date: October 2006

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 designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2665
• Est. primary completion date: October 2007
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)

• Agreement to maintain the same dose of metformin from screening to the end of the study

• Age in the range of 18-80 years

• Body mass index (BMI) in the range of 22-40 kg/m2

• HbA1c in the range of 7.0 to 10%

• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

• A history of type 1 diabetes

• Liver disease

• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• vildagliptin
vildagliptin as add-on to metformin
• thiazolidinedione (TZD)
TZD add-on to metformin

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a prima — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HemoglobinA1c (HbA1c)		after 12 weeks of treatment	No
Secondary	Change from baseline in body weight		after 12 weeks of treatment	No
Secondary	Change from baseline in fasting plasma glucose (FPG)		after 12 weeks of treatment	No
Secondary	Incidence of prespecified adverse events while on treatment with study drug		12 week treatment duration	Yes

External Links

•   Results for CLAF237A23119 from the Novartis Clinical Trials website