Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

February 21, 2017 updated by: Novartis

A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

448

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

  • Australia
      • Box Hill, Australia
        • Novartis Investigative Site
      • Heidelberg Heights, Australia
        • Novartis Investigative Site
      • Parkville, Australia
        • Novartis Investigative Site
      • Wollongong, Australia
        • Novartis Investigative Site #1
      • Wollongong, Australia
        • Novartis Investigative Site #2
  • Belgium
      • Bonheiden, Belgium
        • Novartis Investigative Site
      • Edegem, Belgium
        • Novartis Investigative Site
      • Genk, Belgium
        • Novartis Investigative Site
      • La Louviere, Belgium
        • Novartis Investigative Site
      • Ronse, Belgium
        • Novartis Investigative Site
  • Czech Republic
      • Ostrava, Czech Republic
        • Novartis Investigative Site #1
      • Ostrava, Czech Republic
        • Novartis Investigative Site #2
      • Ostrava, Czech Republic
        • Novartis Investigative Site #3
  • Germany
      • Asslar, Germany
        • Novartis Investigative Site
      • Bensheim, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Einbeck, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site #1
      • Hamburg, Germany
        • Novartis Investigative Site #2
      • Hamburg, Germany
        • Novartis Investigative Site #3
      • Hamburg, Germany
        • Novartis Investigative Site #4
      • Hannover, Germany
        • Novartis Investigative Site
      • Kassel, Germany
        • Novartis Investigative Site #1
      • Kassel, Germany
        • Novartis Investigative Site #2
      • Munchen, Germany
        • Novartis Investigative Site
      • Neubukow, Germany
        • Novartis Investigative Site
      • Saarlouis, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala
        • Novartis Investigative Site #1
      • Guatemala City, Guatemala
        • Novartis Investigative Site #2
      • Guatemala City, Guatemala
        • Novartis Investigative Site #3
      • Guatemala City, Guatemala
        • Novartis Investigative Site #4
      • Guatemala City, Guatemala
        • Novartis Investigative Site #5
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site #1
      • Hong Kong, Hong Kong
        • Novartis Investigative Site #2
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site #1
      • Budapest, Hungary
        • Novartis Investigative Site #2
      • Dunaujvaros, Hungary
        • Novartis Investigative Site
      • Nyiregyhaza, Hungary
        • Novartis Investigative Site
      • Szeged, Hungary
        • Novartis Investigative Site
  • India
      • Indore, India
        • Novartis Investigative Site
      • Jaipur, India
        • Novartis Investigative Site
      • Karnal, India
        • Novartis Investigative Site
      • Mumbai, India
        • Novartis Investigative Site #2
      • Mumbia, India
        • Novartis Investigative Site #1
      • Nagpur, India
        • Novartis Investigative Site #1
      • Nagpur, India
        • Novartis Investigative Site #2
      • Nasik, India
        • Novartis Investigative Site
      • Trivandrum, India
        • Novartis Investigative Site #1
      • Trivandrum, India
        • Novartis Investigative Site #2
  • Romania
      • Alba-Iulia, Romania
        • Novartis Investigative Site
      • Bucharest, Romania
        • Novartis Investigative Site
      • Oradea, Romania
        • Novartis Investigative Site #1
      • Oradea, Romania
        • Novartis Investigative Site #2
      • Targu-Mures, Romania
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Novartis Investigative Site
      • Bratislava, Slovakia
        • Novartis Investigative Site #1
      • Bratislava, Slovakia
        • Novartis Investigative Site #2
      • Bratislava, Slovakia
        • Novartis Investigative Site #3
      • Kosice, Slovakia
        • Novartis Investigative Site #1
      • Kosice, Slovakia
        • Novartis Investigative Site #2
      • Presov, Slovakia
        • Novartis Investigative Site
      • Sturovo, Slovakia
        • Novartis Investigative Site
  • United Kingdom
      • Carmarthen, United Kingdom
        • Novartis Investigative Site
      • Glasgow, United Kingdom
        • Novartis Investigative Site #1
      • Glasgow, United Kingdom
        • Novartis Investigative Site #2

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of T2DM
  • On a stable dose of insulin as defined by the protocol
  • On a stable does of metformin (if applicable) as defined by the protocol
  • Age 18 to 80 years
  • HbA1c of 7.5 to 11.0%
  • Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • Short-acting or rapid-acting insulin
  • Pregnancy or lactation
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • 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
Experimental: Vildagliptin
Drug: Vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c reduction
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c reduction in subpopulation treated with insulin and with metformin
Time Frame: 24 weeks
24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin
Time Frame: 24 weeks
24 weeks
Reduction in FPG (overall and subpopulations)
Time Frame: 24 weeks
24 weeks
Responder rates (overall and subpopulations)
Time Frame: 24 weeks
24 weeks
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Novartis

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

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23135

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.

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