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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LCQ908A
LCQ908A
LCQ908A
LCQ908A
LCQ908A
Placebo
Sitagliptin
metformin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Advantage
  • Mesa Family Medical Center/Clinical Research Advantage
  • Woodland International Reserach Group, LLC
  • Associated Pharmaceutical Research
  • John Muir Clinical Research
  • *Private Practice*
  • Apex Research of Riverside
  • California Research Foundation
  • CNRI-San Diego, LLC
  • Orange County Research Center
  • Diablo Clinical
  • Denver VA Medical Center
  • Complete Family Care
  • Research Center Phase I-IV of Florida, Corp.
  • Metabolic Research Institute, Inc.
  • Perimeter North Medical Research
  • MacNeal Center for Clinical Research
  • Venture Resource Group
  • Cotton-O'Neil Clinical Research Center Topeka KS United States
  • Graves Gilbert Clinic Bowling Green KY United States
  • Commonwealth Biomedical Research, LLC
  • Centennial Medical Group
  • International Research Center Towson MD United States
  • Fallon Clinic Worcester MA United States
  • Southwestern Medical Clinic
  • Clarkston Medical Group
  • Michigan State University - Kalamazoo Ctr for Med Studies
  • Mississippi Medical Research, LLC
  • ClinVest Research
  • St. John's Clinic - Medical Research
  • Montana Medical Research
  • Meera Dewan, P.C.
  • Libra Clinical Research Associates
  • Physicians Research Center
  • Endwell Family Physician
  • *Private Practice* Staten Island
  • Medical Frontiers LLC
  • Radiant Research
  • Southwind Medical Specialists Memphis TN United States
  • Dallas Diabetic and Endocrinology Research Center
  • Radiant Research - North Dallas
  • Accurate Clinical Research
  • Blalock Clinical Research
  • Texas Center for Drug Development, P.A.
  • Ettrick Health Center
  • McGuire Veterans Medical Center
  • Northwest Clinical Research
  • Providence Physicians Group
  • Health Sciences Centre - Diabetes Research Group
  • Rivergrove Medical Clinic
  • Credit Valley Prof Bldg
  • Hamilton Medical Research Group
  • Hopital Maisonneuve-Rosemont
  • Institut de Recherches Cliniques
  • Clinique Médicale Millénia Santé
  • CHUS - Hopital Fleurimont
  • Azienda Ospedaliera-Ospedali Riuniti di Bergamo
  • Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
  • A.O.Polo Universitario Luigi Sacco
  • Istituto Scientifico San Raffaele - IRCCS
  • Ospedale S.Giovanni di Dio
  • Presidio Ospedaliero di Cisanello Università degli Studi
  • Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Policlinica Dr. Luis Rodriguez Carrasquillo
  • Endocrine Lipid Diabetes Research Institute Ponce PR United States
  • Miguel Sosa-Padilla, M.D.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

LCQ908 Dose 1

LCQ908 Dose 2

LCQ908 Dose 3

LCQ908 Dose 4

LCQ908 Dose 5

Placebo

Sitagliptin

Arm Description

Outcomes

Primary Outcome Measures

Effect of LCQ on measures of glucose control

Secondary Outcome Measures

Changes in body weight and related measures
Insulin sensitivity
Safety and tolerability

Full Information

First Posted
May 13, 2009
Last Updated
January 3, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00901979
Brief Title
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
693 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCQ908 Dose 1
Arm Type
Experimental
Arm Title
LCQ908 Dose 2
Arm Type
Experimental
Arm Title
LCQ908 Dose 3
Arm Type
Experimental
Arm Title
LCQ908 Dose 4
Arm Type
Experimental
Arm Title
LCQ908 Dose 5
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Sitagliptin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LCQ908A
Intervention Type
Drug
Intervention Name(s)
LCQ908A
Intervention Type
Drug
Intervention Name(s)
LCQ908A
Intervention Type
Drug
Intervention Name(s)
LCQ908A
Intervention Type
Drug
Intervention Name(s)
LCQ908A
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Type
Drug
Intervention Name(s)
metformin
Primary Outcome Measure Information:
Title
Effect of LCQ on measures of glucose control
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight and related measures
Time Frame
12 weeks
Title
Insulin sensitivity
Time Frame
12 weeks
Title
Safety and tolerability
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Advantage
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Mesa Family Medical Center/Clinical Research Advantage
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Woodland International Reserach Group, LLC
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Associated Pharmaceutical Research
City
Buena Park
State/Province
California
Country
United States
Facility Name
John Muir Clinical Research
City
Concord
State/Province
California
Country
United States
Facility Name
*Private Practice*
City
Pasadena
State/Province
California
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
Country
United States
Facility Name
CNRI-San Diego, LLC
City
San Diego
State/Province
California
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
Country
United States
Facility Name
Diablo Clinical
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Complete Family Care
City
Northglenn
State/Province
Colorado
Country
United States
Facility Name
Research Center Phase I-IV of Florida, Corp.
City
Miami
State/Province
Florida
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Perimeter North Medical Research
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
MacNeal Center for Clinical Research
City
Berwyn
State/Province
Illinois
Country
United States
Facility Name
Venture Resource Group
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center Topeka KS United States
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Graves Gilbert Clinic Bowling Green KY United States
City
Bowling Green
State/Province
Kentucky
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
Country
United States
Facility Name
International Research Center Towson MD United States
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Fallon Clinic Worcester MA United States
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Southwestern Medical Clinic
City
Bridgman
State/Province
Michigan
Country
United States
Facility Name
Clarkston Medical Group
City
Clarkston
State/Province
Michigan
Country
United States
Facility Name
Michigan State University - Kalamazoo Ctr for Med Studies
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Mississippi Medical Research, LLC
City
Picayune
State/Province
Mississippi
Country
United States
Facility Name
ClinVest Research
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
St. John's Clinic - Medical Research
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Meera Dewan, P.C.
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Libra Clinical Research Associates
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
Physicians Research Center
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
Endwell Family Physician
City
Endwell
State/Province
New York
Country
United States
Facility Name
*Private Practice* Staten Island
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Medical Frontiers LLC
City
Carlisle
State/Province
Ohio
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Southwind Medical Specialists Memphis TN United States
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Dallas Diabetic and Endocrinology Research Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Radiant Research - North Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
Country
United States
Facility Name
Blalock Clinical Research
City
Houston
State/Province
Texas
Country
United States
Facility Name
Texas Center for Drug Development, P.A.
City
Houston
State/Province
Texas
Country
United States
Facility Name
Ettrick Health Center
City
Ettrick
State/Province
Virginia
Country
United States
Facility Name
McGuire Veterans Medical Center
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Northwest Clinical Research
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Providence Physicians Group
City
Monroe
State/Province
Washington
Country
United States
Facility Name
Health Sciences Centre - Diabetes Research Group
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Rivergrove Medical Clinic
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Credit Valley Prof Bldg
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Hamilton Medical Research Group
City
Sherbrooke
State/Province
Ontario
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Institut de Recherches Cliniques
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Médicale Millénia Santé
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
CHUS - Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Azienda Ospedaliera-Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
City
Chieti
Country
Italy
Facility Name
A.O.Polo Universitario Luigi Sacco
City
Milano
Country
Italy
Facility Name
Istituto Scientifico San Raffaele - IRCCS
City
Milano
Country
Italy
Facility Name
Ospedale S.Giovanni di Dio
City
Olbia
Country
Italy
Facility Name
Presidio Ospedaliero di Cisanello Università degli Studi
City
Pisa
Country
Italy
Facility Name
Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
City
Roma
Country
Italy
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Olawa
Country
Poland
Facility Name
Policlinica Dr. Luis Rodriguez Carrasquillo
City
Carolina
Country
Puerto Rico
Facility Name
Endocrine Lipid Diabetes Research Institute Ponce PR United States
City
Ponce
Country
Puerto Rico
Facility Name
Miguel Sosa-Padilla, M.D.
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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