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
A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, 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 With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy
2 other identifiers
interventional
650
10 countries
40
Brief Summary
This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Oct 2015
Typical duration for phase_3 type-2-diabetes-mellitus
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedStudy Start
First participant enrolled
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2017
CompletedResults Posted
Study results publicly available
September 18, 2018
CompletedDecember 11, 2018
November 1, 2018
1.6 years
September 15, 2015
May 7, 2018
November 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in HbA1c at Week 24
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Baseline and Week 24
Secondary Outcomes (5)
Mean Change From Baseline in Total Body Weight at Week 24
Baseline and Week 24
Percentage of Subjects With Confirmed Hypoglycaemia at Week 24
Baseline and Week 24
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24
Baseline and Week 24
Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24
Baseline and Week 24
Change From Baseline in the Mean Value of 24-hour Glucose at Week 2
Baseline and Week 2
Study Arms (2)
Saxagliptin/Dapagliflozin/Metformin
EXPERIMENTALOral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
Insulin Glargine, Lantos/Metformin
ACTIVE COMPARATORInsulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.
Interventions
Tablets, Oral, 5mg , Once daily, 24 weeks
Tablets, Oral, 10mg , Once daily, 24 weeks
100 Units/ml solution for injection in a prefilled SoloStar pen
Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Eligibility Criteria
You may qualify if:
- At least 18 years of age at screening
- 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
You may not qualify if:
- Clinical diagnosis of Type 1 diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Research Site
Anaheim, California, 92801, United States
Research Site
Los Angeles, California, 90057, United States
Research Site
Miami, Florida, 33144, United States
Research Site
Miami, Florida, 33155, United States
Research Site
St. Petersburg, Florida, 33709, United States
Research Site
Norcross, Georgia, 30071, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Lexington, Kentucky, 40502, United States
Research Site
Quincy, Massachusetts, 02169, United States
Research Site
Beavercreek, Ohio, 45432, United States
Research Site
Norman, Oklahoma, 73069, United States
Research Site
Barto, Pennsylvania, 19504, United States
Research Site
Columbia, South Carolina, 29204, United States
Research Site
Bristol, Tennessee, 37620, United States
Research Site
Kingsport, Tennessee, 37660, United States
Research Site
Houston, Texas, 77004, United States
Research Site
Mesquite, Texas, 74194, United States
Research Site
San Antonio, Texas, 78230, United States
Research Site
San Antonio, Texas, 78258, United States
Research Site
Bountiful, Utah, 84010, United States
Research Site
Karlovy Vary, 360 01, Czechia
Research Site
Olomouc, 772 00, Czechia
Research Site
Copenhagen, 2400, Denmark
Research Site
Budapest, 1032, Hungary
Research Site
Budapest, 1097, Hungary
Research Site
Budapest, 1171, Hungary
Research Site
Guadalajara, 44670, Mexico
Research Site
México, 03800, Mexico
Research Site
Monterrey, 64460, Mexico
Research Site
Zapopan, Jalisco, 45200, Mexico
Research Site
Lodz, 92-003, Poland
Research Site
Nowy Duninów, 09-505, Poland
Research Site
Sochaczew, 96-500, Poland
Research Site
Craiova, 200349, Romania
Research Site
Ploieşti, 100018, Romania
Research Site
Timișoara, 300125, Romania
Research Site
Timișoara, 300456, Romania
Research Site
Lenasia, 1827, South Africa
Research Site
A Coruña, 15006, Spain
Research Site
Uddevalla, 451 80, Sweden
Related Publications (1)
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.
PMID: 31167892DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 16, 2015
Study Start
October 20, 2015
Primary Completion
May 8, 2017
Study Completion
November 10, 2017
Last Updated
December 11, 2018
Results First Posted
September 18, 2018
Record last verified: 2018-11