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OpenTrials
Completed

NCT Number: NCT00382096

Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

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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–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Locations, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
  • Diagnosis of T2DM for at least 4 weeks prior to study entry
  • Age 18 - 78 years inclusive
  • Body mass index (BMI) of 22 - 40 kg/m2
  • HbA1c: 7.5 - 11% inclusive
  • FPG <270 mg/dL (15 mmol/L)

Exclusion criteria

  • Pregnant or lactating female
  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

metformin

Drug

vildagliptin + metformin

Drug

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: At week 24

Secondary outcomes

  1. Change from baseline in fasting plasma glucose

    Time frame: At week 24

  2. Percent of patients with endpoint HbA1c <7%

    Time frame: At week 24

  3. Percent of patients with reduction in HbA1c >/=0.7%

    Time frame: At week 24

  4. Adverse event profile after treatment

    Time frame: At week 24

  5. Change from baseline in body weight

    Time frame: At week 24

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2006
Registry last updated
Dec 19, 2020

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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