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Completed

NCT Number: NCT00383578

Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive 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

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Nuremberg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 65 years to the upper age limit recommended by local prescribing information for metformin
  • Drug naive patients with type 2 diabetes.
  • Body mass index (BMI) in the range of 22-40 kg/m2.
  • HbA1c in the range of 7 to 9% inclusive
  • FPG <270 mg/dL (15 mmol/L)

Exclusion criteria

  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin 100 mg qd

Drug

Metformin 1500 mg daily

Drug

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: after 24 weeks of treatment

Secondary outcomes

  1. Adverse event profile

    Time frame: after 24 weeks of treatment

  2. Gastrointestinal tolerability

    Time frame: after 24 weeks of treatment

  3. Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%

    Time frame: after 24 weeks of treatment

  4. Change from baseline in fasting plasma glucose

    Time frame: after 24 weeks of treatment

  5. Change from baseline in body weight

    Time frame: after 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2008
First posted
Oct 3, 2006
Registry last updated
Dec 17, 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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