Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
NCT ID: NCT01111955
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2010-07-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
NCT01046422
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
NCT00971243
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
NCT00508287
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin
NCT01929863
Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin
NCT02150824
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BMS-823778 (2 mg)
\+ metformin
BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
Metformin
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
BMS-823778 (10 mg)
\+ metformin
BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
Metformin
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
BMS-823778 (20 mg)
\+ metformin
BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
Metformin
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Placebo
\+ metformin
Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Metformin
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Metformin
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Drug naive or on stable metformin therapy
* HbA1c 7-10%
* FPG ≤ 240mg/dL
Exclusion Criteria
* Congestive heart failure
* Active liver disease
* Impaired renal function
* Hepatitis C, B and HIV
This list is not inclusive; additional information is provided in the protocol
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Farid Marquez, Md
Hialeah, Florida, United States
Capital Clinical Reserch Center
Olympia, Washington, United States
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States
Local Institution
Blacktown, New South Wales, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Freemantle, Western Australia, Australia
Local Institution
Surrey, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bathurst, New Brunswick, Canada
Local Institution
St. John's, Newfoundland and Labrador, Canada
Local Institution
Thornhill, Ontario, Canada
Local Institution
Mirabel, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB121-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.