Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
NCT ID: NCT01290575
Last Updated: 2012-03-27
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
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COMPLETED
PHASE1
67 participants
INTERVENTIONAL
2011-02-28
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 15mg, twice daily, 14 day
Arm 2 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 60mg, twice daily, 14 day
Arm 3 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, oral, 150mg, twice daily, 14 day
Arm 4 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 300mg, twice daily, 14 day
Arm 5 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 450mg, twice daily, 14 day
Arm 6 BMS-820132 or placebo
Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Arm 7 BMS-820132 or placebo
Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Arm 8 BMS-820132 or placebo
Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
Arm 9 BMS-820132 or placebo
Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 5 mg, twice daily, 14 day
Interventions
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Placebo
capsule, Oral, 0.0mg, twice daily, 14 day
Placebo
Capsule, Oral, 0.0mg, once daily, 14 day
BMS-820132
Capsule, Oral, 15mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 60mg, twice daily, 14 day
BMS-820132
Capsule, oral, 150mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 300mg, twice daily, 14 day
BMS-820132
Capsule, Oral, 450mg, twice daily, 14 day
BMS-820132
Capsule, Oral, To be determined (TBD), once daily, 14 day
BMS-820132
Capsule, Oral, 5 mg, twice daily, 14 day
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes treated with metformin monotherapy (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
* Body Mass Index (BMI) of 18.5 to 40 kg/m2.
* Fasting glucose in the range of 125-275 mg/dL.
* Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
* Fasting C-peptide \> 1 ng/mL.
Exclusion Criteria
* History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
* Any major surgery within 4 weeks of study drug administration.
* Any gastrointestinal surgery that could impact upon the absorption of study drug.
* Smoking more than 10 cigarettes per day.
* Recent drug or alcohol abuse.
* Women who are pregnant or breastfeeding.
* Positive urine screen for drugs of abuse.
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody.
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Dedicated Phase I, Inc.
Phoenix, Arizona, United States
Osborne Research Center
Little Rock, Arkansas, United States
Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States
Mra Clinical Research
Miami, Florida, United States
Cetero Research
San Antonio, Texas, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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MB122-004
Identifier Type: -
Identifier Source: org_study_id
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