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OpenTrials
Completed

NCT Number: NCT01257451

Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Wichelen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age: ≥ 70 years inclusive at Visit 1.
  • patients with a confirmed diagnosis of T2DM
  • HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
  • body mass index (BMI) in the range of 19-45kg/m2

Exclusion criteria

  • FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
  • previous or current participation in any vildagliptin clinical study.
  • history of hypersensitivity to DPP-4 inhibitors.
  • concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
  • donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

vildagliptin 50mg bid

Placebo

Drug

Placebo 50mg bid

Primary outcomes

  1. To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo

    Time frame: 24 weeks

Secondary outcomes

  1. To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.

    Time frame: 24 weeks

  2. To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo

    Time frame: 24 weeks

  3. To assess the responder rates of patients treated with vildagliptin as compared to placebo

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2010
Registry last updated
Dec 18, 2012

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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