A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT00357370
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, once daily, up to 12 weeks
  • Placebo — DRUG
    Tablets, Oral, 0 mg, once daily, up to 12 weeks

Study Details

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Key Dates

Start date
Oct 31, 2006
Status verified
Mar 2017
Primary completion
Mar 31, 2008
Completion
Mar 31, 2008

Study Design

Enrollment
163 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    20 mg
  • Experimental: Cohort 2 - Arm 1
    10 mg
  • Experimental: Cohort 2 - Arm 2
    20 mg
  • Placebo Comparator: Cohort 2 - Arm 3

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 [ Time Frame: From Baseline to Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Nea ClinicJonesboroArkansas72401-
Valley ResearchFresnoCalifornia93720-
Bernstein, RichardGreenbraeCalifornia94904-
Jacksonville Center For Clinical ResearchJacksonvilleFlorida32205-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
Indiana UniversityIndianapolisIndiana46202-
Model Clinical Research LlcBaltimoreMaryland21204-
University Of MichiganAnn ArborMichigan48109-
St. Louis Center For Clinical ResearchSt LouisMissouri63128-
Suny Upstate Medical UniversitySyracuseNew York13210-
Mountain Diabetes And Endocrine CenterAshevilleNorth Carolina28801-
Your Diabetes Endocrine Nutrition GroupMentorOhio44060-
Research Institute Of Dallas, P.A.DallasTexas75231-
Diabetes And Glandular Disease Research Associates, P.A.San AntonioTexas78229-
Rainier Clinical Research CenterRentonWashington98055-
Advanced Healthcare S.C.MilwaukeeWisconsin53209-

Find similar trials in Jonesboro, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Nea Clinic· Jonesboro, ARValley Research· Fresno, CABernstein, Richard· Greenbrae, CAJacksonville Center For Clinical Research· Jacksonville, FLEndocrine Research Solutions, Inc.· Roswell, GAIndiana University· Indianapolis, IN

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