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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014