Clinical trial NCT00162305: A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
Official title: A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
* Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone.
* HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%

Exclusion Criteria:

* Women of childbearing potential

Primary outcomes:
measure: To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
timeFrame: 14 days
Secondary outcomes:
measure: To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin
timeFrame: 14 days
measure: To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis
timeFrame: 14 days
measure: To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine
timeFrame: 14 days
measure: To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum
timeFrame: 14 days
measure: To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption
timeFrame: 14 days
measure: To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects.
timeFrame: 14 days
measure: To identify potential biomarkers in both urine and blood
timeFrame: 14 days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: San Antonio
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7.