A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
NCT ID: NCT02551874
Last Updated: 2018-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2015-10-20
2017-11-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Saxagliptin/Dapagliflozin/Metformin
Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
Saxagliptin, Onglyza
Tablets, Oral, 5mg , Once daily, 24 weeks
Dapagliflozin, Farxiga
Tablets, Oral, 10mg , Once daily, 24 weeks
Metformin
Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Insulin Glargine, Lantos/Metformin
Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.
Glargine insulin
100 Units/ml solution for injection in a prefilled SoloStar pen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saxagliptin, Onglyza
Tablets, Oral, 5mg , Once daily, 24 weeks
Dapagliflozin, Farxiga
Tablets, Oral, 10mg , Once daily, 24 weeks
Glargine insulin
100 Units/ml solution for injection in a prefilled SoloStar pen
Metformin
Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c ≥ 8% and ≤ 12% at screening
* Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
* Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
* estimated glomerular filtration rate (eGFR) \< 60 ml/ml/1.73m2
* Body Mass Index ≤ 45.0 kg/m2
Exclusion Criteria
* History of ketoacidosis
* Renal, hepatic or pancreatic disease
* Impairment of renal function (defined as creatinine clearance \[CrCl\] \< 60 mL/min
* Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance \[CrCl\] \< 60 mL/min
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Anaheim, California, United States
Research Site
Los Angeles, California, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Norcross, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lexington, Kentucky, United States
Research Site
Quincy, Massachusetts, United States
Research Site
Beavercreek, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Barto, Pennsylvania, United States
Research Site
Columbia, South Carolina, United States
Research Site
Bristol, Tennessee, United States
Research Site
Kingsport, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Mesquite, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Bountiful, Utah, United States
Research Site
Karlovy Vary, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Copenhagen, , Denmark
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Zapopan, Jalisco, , Mexico
Research Site
Lodz, , Poland
Research Site
Nowy Duninów, , Poland
Research Site
Sochaczew, , Poland
Research Site
Craiova, , Romania
Research Site
Ploieşti, , Romania
Research Site
Timișoara, , Romania
Research Site
Timișoara, , Romania
Research Site
Lenasia, , South Africa
Research Site
A Coruña, , Spain
Research Site
Uddevalla, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vilsboll T, Ekholm E, Johnsson E, Dronamraju N, Jabbour S, Lind M. Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial. Diabetes Care. 2019 Aug;42(8):1464-1472. doi: 10.2337/dc18-1988. Epub 2019 Jun 4.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-001702-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV181-369
Identifier Type: -
Identifier Source: org_study_id