Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
NCT ID: NCT00757588
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2008-11-30
2010-04-30
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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Saxagliptin, 5 mg + insulin
Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
Saxagliptin, 5 mg + insulin
Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)
Placebo + insulin
Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
Placebo + insulin
Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin
Interventions
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Saxagliptin, 5 mg + insulin
Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)
Placebo + insulin
Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
* If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
* Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
* Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
* Body mass index of 45 kg/m² or lower
* Fasting C-peptide level of 0.8 ng/mL or higher
Exclusion Criteria
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Active liver disease
* Anemia
* Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
* Use of short- or rapid-acting insulin
* Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
* Congestive heart failure
* Unstable or rapidly progressing renal disease
* History of alcohol or drug abuse within the previous year
* History of hemoglobinopathies
* Unstable major psychiatric disorders
* Immunocompromised status
18 Years
78 Years
ALL
No
Sponsors
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AstraZeneca
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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Clinical Research Advantage, Inc
Tempe, Arizona, United States
Valley Research
Fresno, California, United States
Torrance-Lomita Medical Center
Lomita, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Ritchken & First M.D.'S
San Diego, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Family Care Associates Of Nw Florida
Chipley, Florida, United States
Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.
Marianna, Florida, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Danny W. Jackson P.A.
Rolling Fork, Mississippi, United States
Southgate Medical Group
West Seneca, New York, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States
Texas Center For Drug Development
Houston, Texas, United States
Dgd Research, Inc.
San Antonio, Texas, United States
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States
Local Institution
Calgary, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
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Bathurst, New Brunswick, Canada
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London, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Gatineau, Quebec, Canada
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Laval, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Regina, Saskatchewan, Canada
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Besançon, , France
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Montpellier, , France
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Nantes, , France
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Valenciennes, , France
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Szentes, , Hungary
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Zalaegerszeg-Pozva, , Hungary
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Indore, Madhya Pradesh, India
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Hariyāna, , India
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Mumbai, , India
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Pune, , India
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Pune, , India
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Pune, , India
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Vellore, , India
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Aguascalientes, Aguascalientes, Mexico
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Aguascalientes, Aguascalientes, Mexico
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Zapopan, Jal., Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrrey, Nuevo León, Mexico
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Veracruz, Veracruz, Mexico
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Elblag, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Kursk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Yaroslaval, , Russia
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Parktown, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
Local Institution
Umhlanga, KwaZulu-Natal, South Africa
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Goodwood, Western Cape, South Africa
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Tygerberg, Western Cape, South Africa
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Middlesbrough, Cleveland, United Kingdom
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Salford, Greater Manchester, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Birmingham, West Midlands, United Kingdom
Local Institution
Sheffield, Yorkshire, United Kingdom
Countries
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References
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Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8.
Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1.
Related Links
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Investigator Inquiry form
Other Identifiers
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Eudract-2008-001089-10
Identifier Type: -
Identifier Source: secondary_id
CV181-057
Identifier Type: -
Identifier Source: org_study_id
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