Type 2 Diabetes MellitusPhase 2NCT00901979
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
A Phase 2 study testing LCQ908A, Sitagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 67 sites in 5 countries.
Trial summary
This study will assess the effect of LCQ when added to metformin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LCQ908A, Sitagliptin and metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 693 participants
- Where
- 67 sitesin 5 countries
- Study dates
- Apr 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c from 7.0-10.0%, Stable Metformin dose
Who cannot join
- CHF Class III-IV, Liver disease
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
67 sites in 5 countries.
67 sites in 5 countries
United States48 sites
Northwest Clinical Research
Bellevue, Washington
MacNeal Center for Clinical Research
Berwyn, Illinois
Graves Gilbert Clinic Bowling Green KY United States
Bowling Green, Kentucky
Libra Clinical Research Associates
Brick, New Jersey
Southwestern Medical Clinic
Bridgman, Michigan
Associated Pharmaceutical Research
Buena Park, California
Medical Frontiers LLC
Carlisle, Ohio
Clarkston Medical Group
Clarkston, Michigan
John Muir Clinical Research
Concord, California
Dallas Diabetic and Endocrinology Research Center
Dallas, Texas
Radiant Research - North Dallas
Dallas, Texas
Denver VA Medical Center
Denver, Colorado
Centennial Medical Group
Elkridge, Maryland
Endwell Family Physician
Endwell, New York
Ettrick Health Center
Ettrick, Virginia
Radiant Research
Greer, South Carolina
Accurate Clinical Research
Houston, Texas
Blalock Clinical Research
Houston, Texas
Texas Center for Drug Development, P.A.
Houston, Texas
Michigan State University - Kalamazoo Ctr for Med Studies
Kalamazoo, Michigan
Woodland International Reserach Group, LLC
Little Rock, Arkansas
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky
Southwind Medical Specialists Memphis TN United States
Memphis, Tennessee
Clinical Research Advantage
Mesa, Arizona
Mesa Family Medical Center/Clinical Research Advantage
Mesa, Arizona
Research Center Phase I-IV of Florida, Corp.
Miami, Florida
Montana Medical Research
Missoula, Montana
Providence Physicians Group
Monroe, Washington
Complete Family Care
Northglenn, Colorado
Meera Dewan, P.C.
Omaha, Nebraska
Venture Resource Group
Overland Park, Kansas
*Private Practice*
Pasadena, California
Mississippi Medical Research, LLC
Picayune, Mississippi
McGuire Veterans Medical Center
Richmond, Virginia
Apex Research of Riverside
Riverside, California
Perimeter North Medical Research
Roswell, Georgia
California Research Foundation
San Diego, California
CNRI-San Diego, LLC
San Diego, California
ClinVest Research
Springfield, Missouri
St. John's Clinic - Medical Research
Springfield, Missouri
*Private Practice* Staten Island
Staten Island, New York
Physicians Research Center
Toms River, New Jersey
Cotton-O'Neil Clinical Research Center Topeka KS United States
Topeka, Kansas
International Research Center Towson MD United States
Towson, Maryland
Orange County Research Center
Tustin, California
Diablo Clinical
Walnut Creek, California
Metabolic Research Institute, Inc.
West Palm Beach, Florida
Fallon Clinic Worcester MA United States
Worcester, Massachusetts
Canada8 sites
Credit Valley Prof Bldg
Mississauga, Ontario
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Institut de Recherches Cliniques
Montreal, Quebec
Clinique Médicale Millénia Santé
Québec, Quebec
Hamilton Medical Research Group
Sherbrooke, Ontario
CHUS - Hopital Fleurimont
Sherbrooke, Quebec
Health Sciences Centre - Diabetes Research Group
Winnipeg, Manitoba
Rivergrove Medical Clinic
Winnipeg, Manitoba
Italy7 sites
Azienda Ospedaliera-Ospedali Riuniti di Bergamo
Bergamo
Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
Chieti
A.O.Polo Universitario Luigi Sacco
Milan
Istituto Scientifico San Raffaele - IRCCS
Milan
Ospedale S.Giovanni di Dio
Olbia
Presidio Ospedaliero di Cisanello Università degli Studi
Pisa
Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
Roma
Puerto Rico3 sites
Policlinica Dr. Luis Rodriguez Carrasquillo
Carolina
Endocrine Lipid Diabetes Research Institute Ponce PR United States
Ponce
Miguel Sosa-Padilla, M.D.
San Juan
About this study
This study will assess the effect of LCQ when added to metformin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LCQ908A, Placebo, Sitagliptin, metformin
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCQ908ADrug
LCQ908ADrug
LCQ908ADrug
LCQ908ADrug
LCQ908ADrug
PlaceboDrug
SitagliptinDrug
metforminDrug
| Study group | Role | What they receive |
|---|---|---|
| LCQ908 Dose 1 | Experimental | Not described Receives: Drug: LCQ908A; Drug: metformin |
| LCQ908 Dose 2 | Experimental | Not described Receives: Drug: LCQ908A; Drug: metformin |
| LCQ908 Dose 3 | Experimental | Not described Receives: Drug: LCQ908A; Drug: metformin |
| LCQ908 Dose 4 | Experimental | Not described Receives: Drug: LCQ908A; Drug: metformin |
| LCQ908 Dose 5 | Experimental | Not described Receives: Drug: LCQ908A; Drug: metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: metformin |
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of LCQ on measures of glucose control
Measured: 12 weeks
Secondary outcomes (3)
Changes in body weight and related measures
Measured: 12 weeks
Insulin sensitivity
Measured: 12 weeks
Safety and tolerability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901979
- Sponsor's protocol ID
- CLCQ908A2203
- Status last verified
- Jan 2013
- First submitted
- 13 May 2009
- Last updated
- 9 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT00901979
- Acronym / sponsor ID
- CLCQ908A2203
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effect of LCQ when added to metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| LCQ908 Dose 1 | Experimental | Drug: LCQ908A, Drug: metformin |
| LCQ908 Dose 2 | Experimental | Drug: LCQ908A, Drug: metformin |
| LCQ908 Dose 3 | Experimental | Drug: LCQ908A, Drug: metformin |
| LCQ908 Dose 4 | Experimental | Drug: LCQ908A, Drug: metformin |
| LCQ908 Dose 5 | Experimental | Drug: LCQ908A, Drug: metformin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: metformin |
| Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HbA1c from 7.0-10.0%, Stable Metformin dose
Key exclusion criteria (2 listed)
- CHF Class III-IV, Liver disease
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCQ908A | Drug | LCQ908 Dose 1 |
| LCQ908A | Drug | LCQ908 Dose 2 |
| LCQ908A | Drug | LCQ908 Dose 3 |
| LCQ908A | Drug | LCQ908 Dose 4 |
| LCQ908A | Drug | LCQ908 Dose 5 |
| Placebo | Drug | Placebo |
| Sitagliptin | Drug | Sitagliptin |
| metformin | Drug | LCQ908 Dose 1, LCQ908 Dose 2, LCQ908 Dose 3, LCQ908 Dose 4, LCQ908 Dose 5, Placebo, Sitagliptin |
Primary outcome
Effect of LCQ on measures of glucose control
Time frame: 12 weeks
3 secondary outcomes
Changes in body weight and related measures
Time frame: 12 weeks
Insulin sensitivity
Time frame: 12 weeks
Safety and tolerability
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCQ908A, Sitagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 67 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, Italy, Puerto Rico, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of LCQ on measures of glucose control (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2013.