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NCT00351884 Clinical Trial

Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00351884
Other study ID # CLAF237A23103
Secondary ID
Status Completed
Phase Phase 3
First received July 11, 2006
Last updated November 16, 2016
Start date May 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

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 78 Years
Eligibility Inclusion Criteria:

- Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1

- Body mass index in the range 22-40

- Blood glucose criteria must be met

Exclusion Criteria:

- Pregnancy or lactation

- History of type 1 diabetes

- Evidence of significant diabetic complications

Other protocol-defined inclusion/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

Intervention

Drug:
• Vildagliptin AM

• vildagliptin pm

• placebo

Locations
Country Name City State
Germany Novartis Investigative Site Investigative Centers
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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 24 weeks 24 weeks No
Secondary Safety of vildagliptin in combination with metformin during 24 weeks of treatment 24 weeks Yes
Secondary Change from baseline in fasting plasma glucose at 24 weeks 24 weeks No
Secondary Patients with endpoint HbA1c < 7% after 24 weeks 24 weeks No
Secondary Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks 24 weeks No
Secondary Change from baseline in body weight at 24 weeks 24 weeks No
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