CClinicalTrials.gg
CompletedNCT00901979Updated Jan 9, 2013

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

A Phase 2 interventional study of LCQ908A and LCQ908A in Type 2 Diabetes Mellitus, sponsored by Novartis Pharmaceuticals. Completed at 67 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-09.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
693
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 693 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 229 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion criteria

Exclusion Criteria:

  • CHF Class III-IV, Liver disease

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
693 participants (actual)

Study arms

  • Experimental
    LCQ908 Dose 1

    Drug: LCQ908A · Drug: metformin

  • Experimental
    LCQ908 Dose 2

    Drug: LCQ908A · Drug: metformin

  • Experimental
    LCQ908 Dose 3

    Drug: LCQ908A · Drug: metformin

  • Experimental
    LCQ908 Dose 4

    Drug: LCQ908A · Drug: metformin

  • Experimental
    LCQ908 Dose 5

    Drug: LCQ908A · Drug: metformin

  • Placebo comparator
    Placebo

    Drug: Placebo · Drug: metformin

  • Active comparator
    Sitagliptin

    Drug: Sitagliptin · Drug: metformin

Interventions

  • DrugLCQ908A
  • DrugLCQ908A
  • DrugLCQ908A
  • DrugLCQ908A
  • DrugLCQ908A
  • DrugPlacebo
  • DrugSitagliptin
  • Drugmetformin
06

What researchers measure

Primary outcomes

  1. Effect of LCQ on measures of glucose control

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in body weight and related measures

    Time frame: 12 weeks

  2. Insulin sensitivity

    Time frame: 12 weeks

  3. Safety and tolerability

    Time frame: 12 weeks

07

Study locations

67 sites
  • Clinical Research Advantage
    Mesa, Arizona, United States
  • Mesa Family Medical Center/Clinical Research Advantage
    Mesa, Arizona, United States
  • Woodland International Reserach Group, LLC
    Little Rock, Arkansas, United States
  • Associated Pharmaceutical Research
    Buena Park, California, United States
  • John Muir Clinical Research
    Concord, California, United States
  • *Private Practice*
    Pasadena, California, United States
  • Apex Research of Riverside
    Riverside, California, United States
  • California Research Foundation
    San Diego, California, United States
  • CNRI-San Diego, LLC
    San Diego, California, United States
  • Orange County Research Center
    Tustin, California, United States
  • Diablo Clinical
    Walnut Creek, California, United States
  • Denver VA Medical Center
    Denver, Colorado, United States
  • Complete Family Care
    Northglenn, Colorado, United States
  • Research Center Phase I-IV of Florida, Corp.
    Miami, Florida, United States
  • Metabolic Research Institute, Inc.
    West Palm Beach, Florida, United States
  • Perimeter North Medical Research
    Roswell, Georgia, United States
  • MacNeal Center for Clinical Research
    Berwyn, Illinois, United States
  • Venture Resource Group
    Overland Park, Kansas, United States
  • Cotton-O'Neil Clinical Research Center Topeka KS United States
    Topeka, Kansas, United States
  • Graves Gilbert Clinic Bowling Green KY United States
    Bowling Green, Kentucky, United States
  • Commonwealth Biomedical Research, LLC
    Madisonville, Kentucky, United States
  • Centennial Medical Group
    Elkridge, Maryland, United States
  • International Research Center Towson MD United States
    Towson, Maryland, United States
  • Fallon Clinic Worcester MA United States
    Worcester, Massachusetts, United States
  • Southwestern Medical Clinic
    Bridgman, Michigan, United States
  • Clarkston Medical Group
    Clarkston, Michigan, United States
  • Michigan State University - Kalamazoo Ctr for Med Studies
    Kalamazoo, Michigan, United States
  • Mississippi Medical Research, LLC
    Picayune, Mississippi, United States
  • ClinVest Research
    Springfield, Missouri, United States
  • St. John's Clinic - Medical Research
    Springfield, Missouri, United States
  • Montana Medical Research
    Missoula, Montana, United States
  • Meera Dewan, P.C.
    Omaha, Nebraska, United States
  • Libra Clinical Research Associates
    Brick, New Jersey, United States
  • Physicians Research Center
    Toms River, New Jersey, United States
  • Endwell Family Physician
    Endwell, New York, United States
  • *Private Practice* Staten Island
    Staten Island, New York, United States
  • Medical Frontiers LLC
    Carlisle, Ohio, United States
  • Radiant Research
    Greer, South Carolina, United States
  • Southwind Medical Specialists Memphis TN United States
    Memphis, Tennessee, United States
  • Dallas Diabetic and Endocrinology Research Center
    Dallas, Texas, United States
  • Radiant Research - North Dallas
    Dallas, Texas, United States
  • Accurate Clinical Research
    Houston, Texas, United States
  • Blalock Clinical Research
    Houston, Texas, United States
  • Texas Center for Drug Development, P.A.
    Houston, Texas, United States
  • Ettrick Health Center
    Ettrick, Virginia, United States
  • McGuire Veterans Medical Center
    Richmond, Virginia, United States
  • Northwest Clinical Research
    Bellevue, Washington, United States
  • Providence Physicians Group
    Monroe, Washington, United States
  • Health Sciences Centre - Diabetes Research Group
    Winnipeg, Manitoba, Canada
  • Rivergrove Medical Clinic
    Winnipeg, Manitoba, Canada
  • Credit Valley Prof Bldg
    Mississauga, Ontario, Canada
  • Hamilton Medical Research Group
    Sherbrooke, Ontario, Canada
  • Hopital Maisonneuve-Rosemont
    Montreal, Quebec, Canada
  • Institut de Recherches Cliniques
    Montreal, Quebec, Canada
  • Clinique Médicale Millénia Santé
    Québec, Quebec, Canada
  • CHUS - Hopital Fleurimont
    Sherbrooke, Quebec, Canada
  • Azienda Ospedaliera-Ospedali Riuniti di Bergamo
    Bergamo, Italy
  • Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
    Chieti, Italy
  • A.O.Polo Universitario Luigi Sacco
    Milano, Italy
  • Istituto Scientifico San Raffaele - IRCCS
    Milano, Italy
  • Ospedale S.Giovanni di Dio
    Olbia, Italy
  • Presidio Ospedaliero di Cisanello Università degli Studi
    Pisa, Italy
  • Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
    Roma, Italy
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
    Olawa, Poland
  • Policlinica Dr. Luis Rodriguez Carrasquillo
    Carolina, Puerto Rico
  • Endocrine Lipid Diabetes Research Institute Ponce PR United States
    Ponce, Puerto Rico
  • Miguel Sosa-Padilla, M.D.
    San Juan, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00901979
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
May 14, 2009
Start date
Apr 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jan 9, 2013
View the source record on ClinicalTrials.gov ↗

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