A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.
1 other identifier
interventional
163
2 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Oct 2006
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
May 11, 2017
CompletedMay 11, 2017
March 1, 2017
1.4 years
July 26, 2006
September 30, 2016
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.
From Baseline to Week 12
Secondary Outcomes (5)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
From Baseline to Week 12
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
From Baseline to Week 12
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
From Baseline to Week 12
Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
From Baseline to Week 12
Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
From Baseline to Week 12
Study Arms (4)
Cohort 1
EXPERIMENTAL20 mg
Cohort 2 - Arm 1
EXPERIMENTAL10 mg
Cohort 2 - Arm 2
EXPERIMENTAL20 mg
Cohort 2 - Arm 3
PLACEBO COMPARATORInterventions
Tablets, Oral, once daily, up to 12 weeks
Eligibility Criteria
You may qualify if:
- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index \<=45.0 kg/m2
- Serum creatinine \<1.5 mg/dL for men or \<1.4 mg/dL for women
- No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be \<3 g/24 hrs)
You may not qualify if:
- History of type 1 diabetes
- AST and/or ALT \>2.5 times the upper limit of normal
- Creatinine kinase ≥3 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- History of hypoglycemic unawareness
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (23)
Nea Clinic
Jonesboro, Arkansas, 72401, United States
Valley Research
Fresno, California, 93720, United States
Bernstein, Richard
Greenbrae, California, 94904, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32205, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Model Clinical Research Llc
Baltimore, Maryland, 21204, United States
University Of Michigan
Ann Arbor, Michigan, 48109, United States
St. Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Suny Upstate Medical University
Syracuse, New York, 13210, United States
Mountain Diabetes And Endocrine Center
Asheville, North Carolina, 28801, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060, United States
Research Institute Of Dallas, P.A.
Dallas, Texas, 75231, United States
Diabetes And Glandular Disease Research Associates, P.A.
San Antonio, Texas, 78229, United States
Rainier Clinical Research Center
Renton, Washington, 98055, United States
Advanced Healthcare S.C.
Milwaukee, Wisconsin, 53209, United States
Local Institution
Winnipeg, Manitoba, R3E 3P4, Canada
Local Institution
Bathurst, New Brunswick, E2A 4X7, Canada
Local Institution
Gatineau, Quebec, J8V 2P5, Canada
Local Institution
Laval, Quebec, H7T 2P5, Canada
Local Institution
Longueuil, Quebec, J4N 1L6, Canada
Local Institution
Pointe-Claire, Quebec, H9R 4S3, Canada
Local Institution
Sherbrooke, Quebec, J1G 5K2, Canada
Related Publications (3)
Wilding JP, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 2009 Sep;32(9):1656-62. doi: 10.2337/dc09-0517. Epub 2009 Jun 15.
PMID: 19528367RESULTMellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
PMID: 27461213DERIVEDKohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
PMID: 26894924DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Cohort 1 data provided information on insulin dose adjustment (n=4).
Results Point of Contact
- Title
- Anna Maria Langkilde
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
October 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
May 11, 2017
Results First Posted
May 11, 2017
Record last verified: 2017-03