Clinical trial NCT02419612: 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
Official title: A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Change From Baseline in Total Body Weight at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52
timeFrame: At Week 52
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period
timeFrame: Up to Week 52
measure: Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
timeFrame: Up to Week 156
measure: Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156
timeFrame: At Week 156
measure: Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
timeFrame: Up to Week 156
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: New Port Richey
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Edina
country: United States
facility: Research Site
state: Minnesota
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Cheb
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Krnov
country: Czechia
facility: Research Site
city: Kromeriz
country: Czechia
facility: Research Site
city: Nachod
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ajka
country: Hungary
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Cuautla
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guanajuato
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Oswiecim
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Buzau
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Satu-Mare
country: Romania
facility: Research Site
city: Targu
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St.-Petersburg
country: Russian Federation
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Rättvik
country: Sweden
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.