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
NCT ID: NCT02681094
Last Updated: 2018-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
905 participants
INTERVENTIONAL
2016-02-26
2017-07-15
Brief Summary
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Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
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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+Dapagliflozin+Metformin
5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin
Dapagliflozin
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Saxagliptin
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Dapagliflozin+Saxagliptin placebo+Metformin
5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo
Dapagliflozin
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Placebo for Saxagliptin
Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Saxagliptin+Dapagliflozin placebo+metformin
5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo
Placebo for Dapagliflozin
Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
Saxagliptin
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Interventions
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Dapagliflozin
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Placebo for Dapagliflozin
Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
Saxagliptin
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Placebo for Saxagliptin
Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit;
3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day;
4. BMI ≤45.0kg/m2 at Enrolment visit;
5. Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;
6. For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study medication in such a manner that the risk of pregnancy is minimized.
Exclusion Criteria
2. History of pancreatitis.
3. Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment
4. Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.
5. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody.
6. Moderate or severe impairment of renal function \[defined as Estimated Glomerular Filtration Rate (eGFR) \<60milliLitre/min/1.73 m2 (estimated by Modification in Diet and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in females\]. Conditions of congenital renal glucosuria, history of unstable or rapidly progressing renal disease.
7. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study, may influence the results, or may limit the patient's ability to participate in or complete the study.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Saraland, Alabama, United States
Research Site
Fresno, California, United States
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Harbor City, California, United States
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Hawaiian Gardens, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Pomona, California, United States
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Spring Valley, California, United States
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Vallejo, California, United States
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Denver, Colorado, United States
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Northglenn, Colorado, United States
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Wheat Ridge, Colorado, United States
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Waterbury, Connecticut, United States
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Cooper City, Florida, United States
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Doral, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Buford, Georgia, United States
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Chicago, Illinois, United States
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Hazel Crest, Illinois, United States
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New Orleans, Louisiana, United States
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Zachary, Louisiana, United States
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Biloxi, Mississippi, United States
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Florissant, Missouri, United States
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Albany, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Mooresville, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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Maumee, Ohio, United States
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East Providence, Rhode Island, United States
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West Columbia, South Carolina, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
Research Site
Sugar Land, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Moncton, New Brunswick, Canada
Research Site
Bridgewater, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Lévis, Quebec, Canada
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Mirabel, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
Research Site
Chrudim III, , Czechia
Research Site
České Budějovice, , Czechia
Research Site
Jílové u Prahy, , Czechia
Research Site
Ostrava, , Czechia
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Pardubice, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Prague, , Czechia
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Prague, , Czechia
Research Site
Prague, , Czechia
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Prague, , Czechia
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Praha Klanovice, , Czechia
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Uherské Hradiště, , Czechia
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Berlin, , Germany
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Bünde, , Germany
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Essen, , Germany
Research Site
Giengen an der Brenz, , Germany
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Großheirath, , Germany
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Hof, , Germany
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Hohenmölsen, , Germany
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Karlsruhe, , Germany
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Lichtenfels, , Germany
Research Site
Meine, , Germany
Research Site
Münster, , Germany
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Rehburg-Loccum, , Germany
Research Site
Stolberg, , Germany
Research Site
Villingen-Schwenningen, , Germany
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
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Monterrey, , Mexico
Research Site
Monterrey, , Mexico
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Zapopan, , Mexico
Research Site
Arkhangelsk, , Russia
Research Site
Izhevsk, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Perm, , Russia
Research Site
Perm, , Russia
Research Site
Rostov-on-Don, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Tver', , Russia
Research Site
Ufa, , Russia
Research Site
Vladikavkaz, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Yekaterinburg, , Russia
Countries
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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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D1683C00005
Identifier Type: -
Identifier Source: org_study_id
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