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
1 other identifier
interventional
444
10 countries
84
Brief Summary
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes
Started Aug 2015
Longer than P75 for phase_3 diabetes
84 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
April 14, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedStudy Start
First participant enrolled
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2017
CompletedResults Posted
Study results publicly available
October 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2019
CompletedJune 23, 2020
June 1, 2020
2 years
April 14, 2015
July 12, 2018
June 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Baseline and Week 52
Secondary Outcomes (7)
Change From Baseline in Total Body Weight at Week 52
Baseline and Week 52
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52
At Week 52
Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Baseline and Week 52
Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period
Up to Week 52
Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
Up to Week 156
- +2 more secondary outcomes
Study Arms (2)
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
EXPERIMENTALSaxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Glimepiride or Placebo
EXPERIMENTALGlimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must be willing and able to give signed and dated written informed consent
- 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
You may not qualify if:
- Clinical diagnosis of type I diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (84)
Research Site
Birmingham, Alabama, 35211, United States
Research Site
Chandler, Arizona, 85224, United States
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Tempe, Arizona, 85283, United States
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Huntington Park, California, 90255, United States
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Los Angeles, California, 90057, United States
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Sacramento, California, 95823, United States
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Tarzana, California, 91356, United States
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Waterbury, Connecticut, 06708, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32277, United States
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Kissimmee, Florida, 34744, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33174, United States
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New Port Richey, Florida, 34652, United States
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Palm Harbor, Florida, 34684, United States
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Edina, Minnesota, 55435, United States
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Las Vegas, Nevada, 89128, United States
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Greer, South Carolina, 29651, United States
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Bristol, Tennessee, 37620, United States
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Knoxville, Tennessee, 37912, United States
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Dallas, Texas, 75230, United States
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San Antonio, Texas, 78229, United States
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Cheb, 350 02, Czechia
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Hradec Králové, 503 41, Czechia
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Krnov, 794 01, Czechia
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Kroměříž, 767 01, Czechia
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Náchod, 54701, Czechia
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Prague, 140 00, Czechia
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Prague, 149 00, Czechia
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Dresden, 01307, Germany
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Leipzig, 04249, Germany
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Ajka, 8400, Hungary
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Balatonfüred, 8230, Hungary
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Budapest, 1033, Hungary
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Budapest, 1089, Hungary
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Budapest, Hungary
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Debrecen, 4032, Hungary
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Eger, 3300, Hungary
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Kecskemét, 6000, Hungary
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Nyíregyháza, 4405, Hungary
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Zalaegerszeg, 8900, Hungary
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31237, Mexico
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Cuautla, 62746, Mexico
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Guadalajara, 44600, Mexico
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Guanajuato City, 38000, Mexico
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Monterrey, 64460, Mexico
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Veracruz, 91910, Mexico
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Bialystok, 15-351, Poland
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Katowice, 40-648, Poland
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Krakow, 31-156, Poland
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Krakow, 31-261, Poland
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Lodz, 90-242, Poland
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Opole, 45-367, Poland
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Oświęcim, 32-600, Poland
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Poznan, 61-655, Poland
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Warsaw, 00-465, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-349, Poland
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Brasov, 500269, Romania
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Bucharest, 020045, Romania
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Bucharest, 020359, Romania
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Buzău, 120203, Romania
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Galati, 800291, Romania
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Oradea, 410032, Romania
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Oradea, 410169, Romania
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Ploieşti, 100163, Romania
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Ploieşti, 100342, Romania
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Satu Mare, 440055, Romania
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Târgu Gânguleşti, 540142, Romania
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Timișoara, 300736, Romania
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Novosibirsk, 630087, Russia
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Saint Petersburg, 190013, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195176, Russia
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Saint Petersburg, 195257, Russia
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Saint Petersburg, 196084, Russia
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Smolensk, 214018, Russia
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Gothenburg, 413 45, Sweden
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Helsingborg, 25220, Sweden
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Rättvik, 79530, Sweden
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Dundee, DD1 9SY, United Kingdom
Related Publications (1)
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.
PMID: 32052516DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2015
First Posted
April 17, 2015
Study Start
August 14, 2015
Primary Completion
August 29, 2017
Study Completion
September 18, 2019
Last Updated
June 23, 2020
Results First Posted
October 19, 2018
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.