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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00396227
First received: November 2, 2006
Last updated: October 10, 2008
Last verified: October 2008
History of Changes
  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 3

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:

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 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 May 19, 2013