A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

January 3, 2013 updated by: Novartis Pharmaceuticals
This study will assess the effect of LCQ when added to metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

693

Phase

  • Phase 2

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Health Sciences Centre - Diabetes Research Group
      • Winnipeg, Manitoba, Canada
        • Rivergrove Medical Clinic
    • Ontario
      • Mississauga, Ontario, Canada
        • Credit Valley Prof Bldg
      • Sherbrooke, Ontario, Canada
        • Hamilton Medical Research Group
    • Quebec
      • Montreal, Quebec, Canada
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada
        • Institut de Recherches Cliniques
      • Québec, Quebec, Canada
        • Clinique Médicale Millénia Santé
      • Sherbrooke, Quebec, Canada
        • CHUS - Hôpital Fleurimont
  • Italy
      • Bergamo, Italy
        • Azienda Ospedaliera-Ospedali Riuniti di Bergamo
      • Chieti, Italy
        • Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
      • Milano, Italy
        • A.O.Polo Universitario Luigi Sacco
      • Milano, Italy
        • Istituto Scientifico San Raffaele - IRCCS
      • Olbia, Italy
        • Ospedale S.Giovanni di Dio
      • Pisa, Italy
        • Presidio Ospedaliero di Cisanello Università degli Studi
      • Roma, Italy
        • Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
  • Poland
      • Olawa, Poland
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Puerto Rico
      • Carolina, Puerto Rico
        • Policlinica Dr. Luis Rodriguez Carrasquillo
      • Ponce, Puerto Rico
        • Endocrine Lipid Diabetes Research Institute Ponce PR United States
      • San Juan, Puerto Rico
        • Miguel Sosa-Padilla, M.D.
  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Clinical Research Advantage
      • Mesa, Arizona, United States
        • Mesa Family Medical Center/Clinical Research Advantage
    • Arkansas
      • Little Rock, Arkansas, United States
        • Woodland International Reserach Group, LLC
    • California
      • Buena Park, California, United States
        • Associated Pharmaceutical Research
      • Concord, California, United States
        • John Muir Clinical Research
      • Pasadena, California, United States
        • *Private Practice*
      • Riverside, California, United States
        • Apex Research of Riverside
      • San Diego, California, United States
        • California Research Foundation
      • San Diego, California, United States
        • CNRI-San Diego, LLC
      • Tustin, California, United States
        • Orange County Research Center
      • Walnut Creek, California, United States
        • Diablo Clinical
    • Colorado
      • Denver, Colorado, United States
        • Denver VA Medical Center
      • Northglenn, Colorado, United States
        • Complete Family Care
    • Florida
      • Miami, Florida, United States
        • Research Center Phase I-IV of Florida, Corp.
      • West Palm Beach, Florida, United States
        • Metabolic Research Institute, Inc.
    • Georgia
      • Roswell, Georgia, United States
        • Perimeter North Medical Research
    • Illinois
      • Berwyn, Illinois, United States
        • MacNeal Center for Clinical Research
    • Kansas
      • Overland Park, Kansas, United States
        • Venture Resource Group
      • Topeka, Kansas, United States
        • Cotton-O'Neil Clinical Research Center Topeka KS United States
    • Kentucky
      • Bowling Green, Kentucky, United States
        • Graves Gilbert Clinic Bowling Green KY United States
      • Madisonville, Kentucky, United States
        • Commonwealth Biomedical Research, LLC
    • Maryland
      • Elkridge, Maryland, United States
        • Centennial Medical Group
      • Towson, Maryland, United States
        • International Research Center Towson MD United States
    • Massachusetts
      • Worcester, Massachusetts, United States
        • Fallon Clinic Worcester MA United States
    • Michigan
      • Bridgman, Michigan, United States
        • Southwestern Medical Clinic
      • Clarkston, Michigan, United States
        • Clarkston Medical Group
      • Kalamazoo, Michigan, United States
        • Michigan State University - Kalamazoo Ctr for Med Studies
    • Mississippi
      • Picayune, Mississippi, United States
        • Mississippi Medical Research, LLC
    • Missouri
      • Springfield, Missouri, United States
        • Clinvest Research
      • Springfield, Missouri, United States
        • St. John's Clinic - Medical Research
    • Montana
      • Missoula, Montana, United States
        • Montana Medical Research
    • Nebraska
      • Omaha, Nebraska, United States
        • Meera Dewan, P.C.
    • New Jersey
      • Brick, New Jersey, United States
        • Libra Clinical Research Associates
      • Toms River, New Jersey, United States
        • Physicians Research Center
    • New York
      • Endwell, New York, United States
        • Endwell Family Physician
      • Staten Island, New York, United States
        • *Private Practice* Staten Island
    • Ohio
      • Carlisle, Ohio, United States
        • Medical Frontiers LLC
    • South Carolina
      • Greer, South Carolina, United States
        • Radiant Research
    • Tennessee
      • Memphis, Tennessee, United States
        • Southwind Medical Specialists Memphis TN United States
    • Texas
      • Dallas, Texas, United States
        • Dallas Diabetic and Endocrinology Research Center
      • Dallas, Texas, United States
        • Radiant Research - North Dallas
      • Houston, Texas, United States
        • Accurate Clinical Research
      • Houston, Texas, United States
        • Blalock Clinical Research
      • Houston, Texas, United States
        • Texas Center For Drug Development, P.A.
    • Virginia
      • Ettrick, Virginia, United States
        • Ettrick Health Center
      • Richmond, Virginia, United States
        • McGuire Veterans Medical Center
    • Washington
      • Bellevue, Washington, United States
        • Northwest Clinical Research
      • Monroe, Washington, United States
        • Providence Physicians Group

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion Criteria:

  • CHF Class III-IV, Liver disease

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
Drug: metformin
Experimental: LCQ908 Dose 1
Drug: metformin
Drug: LCQ908A
Experimental: LCQ908 Dose 2
Drug: metformin
Drug: LCQ908A
Experimental: LCQ908 Dose 3
Drug: metformin
Drug: LCQ908A
Experimental: LCQ908 Dose 4
Drug: metformin
Drug: LCQ908A
Experimental: LCQ908 Dose 5
Drug: metformin
Drug: LCQ908A
Active Comparator: Sitagliptin
Drug: metformin
Drug: Sitagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of LCQ on measures of glucose control
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight and related measures
Time Frame: 12 weeks
12 weeks
Insulin sensitivity
Time Frame: 12 weeks
12 weeks
Safety and tolerability
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCQ908A2203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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 Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe