Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride (Vildagliptin)

February 21, 2017 updated by: Novartis

A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

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, Australia
        • Novartis Investigative Site
      • Parkville, Australia
        • Novartis Investigative Site
      • St. Leonards, Australia
        • Novartis Investigative Site
  • Germany
      • Anderbeck, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site #1
      • Berlin, Germany
        • Novartis Investigative Site #2
      • Berlin, Germany
        • Novartis Investigative Site #3
      • Berlin, Germany
        • Novartis Investigative Site #4
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hildesheim, Germany
        • Novartis Investigative Site
      • Sangerhausen, Germany
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Erd, Hungary
        • Novartis Investigative Site
      • Torokbalint, Hungary
        • Novartis Investigative Site
  • Italy
      • Bergamo, Italy
        • Novartis Investigative Site
      • Cosenza, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Padova, Italy
        • Novartis Investigative Site
      • Pisa, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site #1
      • Roma, Italy
        • Novartis Investigative Site #2
      • Torino, Italy
        • Novartis Investigative Site
  • Korea, Republic of
      • Bundang, Korea, Republic of
        • Novartis Investigative Site
      • Seoul, Korea, Republic of
        • Novartis Investigative Site #1
      • Seoul, Korea, Republic of
        • Novartis Investigative Site #2
      • Seoul, Korea, Republic of
        • Novartis Investigative Site #3
      • Suwon, Korea, Republic of
        • Novartis Investigative Site
  • Mexico
      • Aguascalientes, Mexico
        • Novartis Investigative Site #1
      • Aguascalientes, Mexico
        • Novartis Investigative Site #2
      • Aguascalientes, Mexico
        • Novartis Investigative Site #3
      • Durango, Mexico
        • Novartis Investigative Site #1
      • Durango, Mexico
        • Novartis Investigative Site #2
      • Durango, Mexico
        • Novartis Investigative Site #3
      • Guadalajara, Mexico
        • Novartis Investigative Site #1
      • Guadalajara, Mexico
        • Novartis Investigative Site #2
      • Guadalajara, Mexico
        • Novartis Investigative Site #3
      • Guadalajara, Mexico
        • Novartis Investigative Site #4
      • Guadalajara, Mexico
        • Novartis Investigative Site #5
      • Mexico, Mexico
        • Novartis Investigative Site
      • Pachuca, Mexico
        • Novartis Investigative Site #1
      • Pachuca, Mexico
        • Novartis Investigative Site #2
      • Pachuca, Mexico
        • Novartis Investigative Site #3
  • Philippines
      • Manila, Philippines
        • Novartis Investigative Site
      • Quezon City, Philippines
        • Novartis Investigative Site #1
      • Quezon City, Philippines
        • 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
  • Taiwan
      • Changhua, Taiwan
        • Novartis Investigative Site
      • Taichung, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
      • Yongkang, Taiwan
        • 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Confirmed diagnosis of T2DM by standard criteria.
  • Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
  • Age: ≥18 to ≤ 80 years
  • HbA1c of ≥ 7.5 and ≤ 11.0%
  • Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

  • FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
  • Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Acute infections which may affect blood glucose control within 4 weeks prior to screening 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vildagliptin (metformin + glimepiride)
Drug: Vildagliptin
Placebo Comparator: Placebo (metformin + glimepiride)
Drug: Placebo

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
FPG reduction
Time Frame: 24 weeks
24 weeks
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
Time Frame: 24 weeks
24 weeks
Responder Rate
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

October 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23152
  • EudraCT 2010-021097-11

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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