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

NCT ID: NCT00901979

Last Updated: 2013-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-06-30

Brief Summary

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This study will assess the effect of LCQ when added to metformin.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCQ908 Dose 1

Group Type EXPERIMENTAL

LCQ908A

Intervention Type DRUG

metformin

Intervention Type DRUG

LCQ908 Dose 2

Group Type EXPERIMENTAL

LCQ908A

Intervention Type DRUG

metformin

Intervention Type DRUG

LCQ908 Dose 3

Group Type EXPERIMENTAL

LCQ908A

Intervention Type DRUG

metformin

Intervention Type DRUG

LCQ908 Dose 4

Group Type EXPERIMENTAL

LCQ908A

Intervention Type DRUG

metformin

Intervention Type DRUG

LCQ908 Dose 5

Group Type EXPERIMENTAL

LCQ908A

Intervention Type DRUG

metformin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

metformin

Intervention Type DRUG

Sitagliptin

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

metformin

Intervention Type DRUG

Interventions

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LCQ908A

Intervention Type DRUG

LCQ908A

Intervention Type DRUG

LCQ908A

Intervention Type DRUG

LCQ908A

Intervention Type DRUG

LCQ908A

Intervention Type DRUG

Placebo

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion Criteria

* CHF Class III-IV, Liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Advantage

Mesa, Arizona, United States

Site Status

Mesa Family Medical Center/Clinical Research Advantage

Mesa, Arizona, United States

Site Status

Woodland International Reserach Group, LLC

Little Rock, Arkansas, United States

Site Status

Associated Pharmaceutical Research

Buena Park, California, United States

Site Status

John Muir Clinical Research

Concord, California, United States

Site Status

*Private Practice*

Pasadena, California, United States

Site Status

Apex Research of Riverside

Riverside, California, United States

Site Status

California Research Foundation

San Diego, California, United States

Site Status

CNRI-San Diego, LLC

San Diego, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Diablo Clinical

Walnut Creek, California, United States

Site Status

Denver VA Medical Center

Denver, Colorado, United States

Site Status

Complete Family Care

Northglenn, Colorado, United States

Site Status

Research Center Phase I-IV of Florida, Corp.

Miami, Florida, United States

Site Status

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status

Perimeter North Medical Research

Roswell, Georgia, United States

Site Status

MacNeal Center for Clinical Research

Berwyn, Illinois, United States

Site Status

Venture Resource Group

Overland Park, Kansas, United States

Site Status

Cotton-O'Neil Clinical Research Center Topeka KS United States

Topeka, Kansas, United States

Site Status

Graves Gilbert Clinic Bowling Green KY United States

Bowling Green, Kentucky, United States

Site Status

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, United States

Site Status

Centennial Medical Group

Elkridge, Maryland, United States

Site Status

International Research Center Towson MD United States

Towson, Maryland, United States

Site Status

Fallon Clinic Worcester MA United States

Worcester, Massachusetts, United States

Site Status

Southwestern Medical Clinic

Bridgman, Michigan, United States

Site Status

Clarkston Medical Group

Clarkston, Michigan, United States

Site Status

Michigan State University - Kalamazoo Ctr for Med Studies

Kalamazoo, Michigan, United States

Site Status

Mississippi Medical Research, LLC

Picayune, Mississippi, United States

Site Status

ClinVest Research

Springfield, Missouri, United States

Site Status

St. John's Clinic - Medical Research

Springfield, Missouri, United States

Site Status

Montana Medical Research

Missoula, Montana, United States

Site Status

Meera Dewan, P.C.

Omaha, Nebraska, United States

Site Status

Libra Clinical Research Associates

Brick, New Jersey, United States

Site Status

Physicians Research Center

Toms River, New Jersey, United States

Site Status

Endwell Family Physician

Endwell, New York, United States

Site Status

*Private Practice* Staten Island

Staten Island, New York, United States

Site Status

Medical Frontiers LLC

Carlisle, Ohio, United States

Site Status

Radiant Research

Greer, South Carolina, United States

Site Status

Southwind Medical Specialists Memphis TN United States

Memphis, Tennessee, United States

Site Status

Dallas Diabetic and Endocrinology Research Center

Dallas, Texas, United States

Site Status

Radiant Research - North Dallas

Dallas, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Blalock Clinical Research

Houston, Texas, United States

Site Status

Texas Center for Drug Development, P.A.

Houston, Texas, United States

Site Status

Ettrick Health Center

Ettrick, Virginia, United States

Site Status

McGuire Veterans Medical Center

Richmond, Virginia, United States

Site Status

Northwest Clinical Research

Bellevue, Washington, United States

Site Status

Providence Physicians Group

Monroe, Washington, United States

Site Status

Health Sciences Centre - Diabetes Research Group

Winnipeg, Manitoba, Canada

Site Status

Rivergrove Medical Clinic

Winnipeg, Manitoba, Canada

Site Status

Credit Valley Prof Bldg

Mississauga, Ontario, Canada

Site Status

Hamilton Medical Research Group

Sherbrooke, Ontario, Canada

Site Status

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Institut de Recherches Cliniques

Montreal, Quebec, Canada

Site Status

Clinique Médicale Millénia Santé

Québec, Quebec, Canada

Site Status

CHUS - Hopital Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Azienda Ospedaliera-Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status

Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio

Chieti, , Italy

Site Status

A.O.Polo Universitario Luigi Sacco

Milan, , Italy

Site Status

Istituto Scientifico San Raffaele - IRCCS

Milan, , Italy

Site Status

Ospedale S.Giovanni di Dio

Olbia, , Italy

Site Status

Presidio Ospedaliero di Cisanello Università degli Studi

Pisa, , Italy

Site Status

Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale

Roma, , Italy

Site Status

Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Oława, , Poland

Site Status

Policlinica Dr. Luis Rodriguez Carrasquillo

Carolina, , Puerto Rico

Site Status

Endocrine Lipid Diabetes Research Institute Ponce PR United States

Ponce, , Puerto Rico

Site Status

Miguel Sosa-Padilla, M.D.

San Juan, , Puerto Rico

Site Status

Countries

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United States Canada Italy Poland Puerto Rico

Other Identifiers

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CLCQ908A2203

Identifier Type: -

Identifier Source: org_study_id

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