Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

December 14, 2012 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Buizingen, Belgium, 1501
        • Novartis Investigative Site
      • De Pinte, Belgium, 9840
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Mouscron, Belgium, 7700
        • Novartis Investigative Site
      • Nazareth, Belgium, 9810
        • Novartis Investigative Site
      • Oostham, Belgium, 3945
        • Novartis Investigative Site
      • Wichelen, Belgium, 9260
        • Novartis Investigative Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Novartis Investigative Site
      • Dimitrovgrad, Bulgaria, 6400
        • Novartis Investigative Site
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4001
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Varna, Bulgaria, 9002
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00180
        • Novartis Investigative Site
      • Oulu, Finland, FIN-90100
        • Novartis Investigative Site
    • Suomi
      • Lahti, Suomi, Finland, 15110
        • Novartis Investigative Site
  • Germany
      • Bamberg, Germany, 96050
        • Novartis Investigative Site
      • Beckum, Germany, 59269
        • Novartis Investigative Site
      • Berlin, Germany, 10115
        • Novartis Investigative Site
      • Falkensee, Germany, 14612
        • Novartis Investigative Site
      • Lichtenfels, Germany, 96215
        • Novartis Investigative Site
      • Lutherstadt Eisleben, Germany, 06295
        • Novartis Investigative Site
      • Magdeburg, Germany, 39112
        • Novartis Investigative Site
      • Mammendorf, Germany, 82291
        • Novartis Investigative Site
      • Münster, Germany, 48143
        • Novartis Investigative Site
      • Potsdam, Germany, 14469
        • Novartis Investigative Site
      • Sulzbach-Rosenberg, Germany, 92237
        • Novartis Investigative Site
      • Völlkingen, Germany, 66333
        • Novartis Investigative Site
      • Wetter, Germany, 58300
        • Novartis Investigative Site
  • Slovakia
      • Kosice, Slovakia, 040 22
        • Novartis Investigative Site
      • Levice, Slovakia, 934 01
        • Novartis Investigative Site
      • Nové Zámky, Slovakia, 940 01
        • Novartis Investigative Site
      • Pie¿¿any, Slovakia, 92101
        • Novartis Investigative Site
      • Ruzomberok, Slovakia, 034 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 811 02
        • Novartis Investigative Site
      • Lubochna, Slovak Republic, Slovakia, 03491
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03114
        • Novartis Investigative Site
    • Andalucía
      • Sanlúcar de Barrameda, Andalucía, Spain, 11540
        • Novartis Investigative Site
    • Barcelona
      • Centelles, Barcelona, Spain, 08540
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alzira, Comunidad Valenciana, Spain, 46600
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Novartis Investigative Site
      • Exeter, United Kingdom, EX2 5DW
        • Novartis Investigative Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novartis Investigative Site
      • Wiltshire, United Kingdom, SN15 2SB
        • Novartis Investigative Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo 50mg bid
Experimental: Vildagliptin
Drug: Vildagliptin
vildagliptin 50mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
Time Frame: 24 weeks
24 weeks
To assess the responder rates of patients treated with vildagliptin as compared to placebo
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23150
  • 2010-022658-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Vildagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe