Clinical trial NCT02284893: 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
Official title: A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 461
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: Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.


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

Inclusion Criteria:

* Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
* Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
* BMI \> 20.0 kg/m2 at the enrollment visit
* Males and Females, age ≥18 years old at time of screening visit
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
* Women must not be breastfeeding

Exclusion Criteria:

* Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
* History of diabetic ketoacidosis
* Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit

  * Myocardial infarction
  * Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft \[(CABG)\]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty \[(PTCA)\])
  * Unstable angina
  * Unstable congestive heart failure (CHF)
  * Transient ischemic attack (TIA) or significant cerebrovascular disease
  * Unstable or previously undiagnosed arrhythmia
  * Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
* Renal Disease
* Hepatic Diseases
* Hematological and Oncological Disease/Conditions
* Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
* Abnormal Free T4

Primary outcomes:
measure: Mean Change in HbA1c
timeFrame: Baseline (randomization) to Week 26
Secondary outcomes:
measure: Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
timeFrame: week 26
measure: Mean Change in Total Body Weight
timeFrame: Baseline (randomization) to Week 26
measure: Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (randomization) to Week 26
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Lomita
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Norwalk
country: United States
facility: Research Site
state: California
city: Paramount
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: Tustin
country: United States
facility: Research Site
state: California
city: Golden
country: United States
facility: Research Site
state: Colorado
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Miami Beach
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: Miami
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Council Bluffs
country: United States
facility: Research Site
state: Iowa
city: Crestview Hills
country: United States
facility: Research Site
state: Kentucky
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Morehead City
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: North Richland Hills
country: United States
facility: Research Site
state: Texas
city: Pasadena
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Suffolk
country: United States
facility: Research Site
state: Virginia
city: Kenosha
country: United States
facility: Research Site
state: Wisconsin
city: Baja
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: Gyula
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Szekszárd
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: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Gdańsk
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: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
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: Craiova
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Satu-Mare
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Boksburg North
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Lenasia
country: South Africa
facility: Research Site
city: Moloto
country: South Africa
facility: Research Site
city: Soweto
country: South Africa
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Astra Zeneca
role: STUDY_DIRECTOR
References: