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OpenTrials
Completed

NCT Number: NCT00396227

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 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

vildagliptin as add-on to metformin

Other names: Galvus

Thiazolidinedione (TZD)

Drug

TZD add-on to metformin

Other names: Actos (pioglitazone), Avandia (rosiglitazone)

Primary outcomes

  1. Change from baseline in HemoglobinA1c (HbA1c)

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: after 12 weeks of treatment

  2. Change from baseline in fasting plasma glucose (FPG)

    Time frame: after 12 weeks of treatment

  3. Incidence of prespecified adverse events while on treatment with study drug

    Time frame: 12 week treatment duration

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
First posted
Nov 6, 2006
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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