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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00396227

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin Drug: thiazolidinedione (TZD)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate Vildagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HemoglobinA1c (HbA1c) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in body weight [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Incidence of prespecified adverse events while on treatment with study drug [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: Yes ]

Enrollment:	2665
Study Start Date:	October 2006
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Vildagliptin 100mg + Met	Drug: vildagliptin vildagliptin as add-on to metformin Other Name: Galvus
Active Comparator: TZD TZD + metformin	Drug: thiazolidinedione (TZD) TZD add-on to metformin Other Name: Actos (pioglitazone), Avandia (rosiglitazone)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396227

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00396227 History of Changes
Other Study ID Numbers:	CLAF237A23119
Study First Received:	November 2, 2006
Last Updated:	October 10, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
2,4-thiazolidinedione
Vildagliptin

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012