A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
NCT ID: NCT02419612
Last Updated: 2020-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2015-08-14
2019-09-18
Brief Summary
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A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Saxagliptin
Dapagliflozin
Placebo
Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Glimepiride
Placebo
Interventions
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Saxagliptin
Dapagliflozin
Glimepiride
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
* Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
* Males and females, aged ≥18 years old at time of screening visit
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
* WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug
Exclusion Criteria
* History of diabetic ketoacidosis
* Cardiovascular/vascular diseases within 3 months of the enrollment
* Renal disease
* Hepatic diseases
* History of, or currently, acute or chronic pancreatitis
* Hematological and oncological disease/conditions
* Patients who have contraindications to therapy being studied
* Patients on weight loss program(s)
* Replacement or chronic systemic corticosteroid therapy
18 Years
120 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Chandler, Arizona, United States
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Tempe, Arizona, United States
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Huntington Park, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Tarzana, California, United States
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Waterbury, Connecticut, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Palm Harbor, Florida, United States
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Edina, Minnesota, United States
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Las Vegas, Nevada, United States
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Greer, South Carolina, United States
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Bristol, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Cheb, , Czechia
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Hradec Králové, , Czechia
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Krnov, , Czechia
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Kroměříž, , Czechia
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Náchod, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Dresden, , Germany
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Leipzig, , Germany
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Ajka, , Hungary
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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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Debrecen, , Hungary
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Eger, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Zalaegerszeg, , Hungary
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Cuautla, , Mexico
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Guadalajara, , Mexico
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Guanajuato City, , Mexico
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Monterrey, , Mexico
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Veracruz, , Mexico
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Bialystok, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Opole, , Poland
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Oświęcim, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Buzău, , Romania
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Galati, , Romania
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Oradea, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
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Ploieşti, , Romania
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Satu Mare, , Romania
Research Site
Târgu Gânguleşti, , Romania
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Timișoara, , Romania
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Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
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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Smolensk, , Russia
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Gothenburg, , Sweden
Research Site
Helsingborg, , Sweden
Research Site
Rättvik, , Sweden
Research Site
Dundee, , United Kingdom
Countries
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References
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Frias JP, Gonzalez-Galvez G, Johnsson E, Maaske J, Testa MA, Simonson DC, Dronamraju N, Garcia-Sanchez R, Peters AL. Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial. Diabetes Obes Metab. 2020 Jul;22(7):1083-1093. doi: 10.1111/dom.13997. Epub 2020 Mar 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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CV181-365
Identifier Type: -
Identifier Source: org_study_id
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