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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
693

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Effect of LCQ on measures of glucose control
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings