Clinical trial NCT00357370: A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-07-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
timeFrame: From Baseline to Week 12
measure: Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
timeFrame: From Baseline to Week 12
measure: Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
timeFrame: From Baseline to Week 12
measure: Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
timeFrame: From Baseline to Week 12
measure: Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Nea Clinic
state: Arkansas
city: Fresno
country: United States
facility: Valley Research
state: California
city: Greenbrae
country: United States
facility: Bernstein, Richard
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Model Clinical Research Llc
state: Maryland
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: St. Louis
country: United States
facility: St. Louis Center For Clinical Research
state: Missouri
city: Syracuse
country: United States
facility: Suny Upstate Medical University
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes And Endocrine Center
state: North Carolina
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group
state: Ohio
city: Dallas
country: United States
facility: Research Institute Of Dallas, P.A.
state: Texas
city: San Antonio
country: United States
facility: Diabetes And Glandular Disease Research Associates, P.A.
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare S.C.
state: Wisconsin
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Bathurst
country: Canada
facility: Local Institution
state: New Brunswick
city: Gatineau
country: Canada
facility: Local Institution
state: Quebec
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Longueuil
country: Canada
facility: Local Institution
state: Quebec
city: Pointe-Claire
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Mellander 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.
citation: Kohan 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.