Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
NCT ID: NCT00508287
Last Updated: 2009-03-16
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
PHASE1
36 participants
INTERVENTIONAL
2007-08-31
2007-11-30
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 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
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
NCT01046422
GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
NCT00291356
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
NCT01111955
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
NCT00698230
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
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
BMS-686117
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
B
Byetta
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
C
Placebo
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-686117
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Byetta
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
Placebo
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fasting plasma glucose: 126 - 240 mg/dL
* Hemoglobin A1c: 6 - 10%
* Estimated CrCl ≥ 60 mL/min
* ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN
* Stable and well controlled hypertension and/or dyslipidemia
* Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
Exclusion Criteria
* Symptomatic diabetes with polyuria and/or polydipsia
* History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
* History of renal disease including diabetic nephropathy
18 Years
70 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.
Bristol-Myers Squibb
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.
Elite Research Institute
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB110-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.