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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284893
• Other study ID #: CV181-363
• Secondary ID: 2014-001102-17
• Status: Completed
• Phase: Phase 3
• Start date: September 9, 2014
• Est. completion date: September 20, 2016

Study information

• Verified date: May 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: September 20, 2016
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
administered orally once daily
• Dapagliflozin
administered orally once daily
• Sitagliptin
administered orally once daily
• Placebo matching with Saxagliptin
administered orally once daily
• Placebo matching with Dapagliflozin
administered orally once daily
• Placebo matching with Sitagliptin
administered orally once daily

Locations

Country	Name	City	State
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyula
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Szekszárd
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Chihuahua
Mexico	Research Site	Cuautla
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Monterrey
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Opole
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Buzau
Romania	Research Site	Craiova
Romania	Research Site	Galati
Romania	Research Site	Oradea
Romania	Research Site	Satu-Mare
Romania	Research Site	Timisoara
South Africa	Research Site	Boksburg North
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Lenasia
South Africa	Research Site	Moloto
South Africa	Research Site	Soweto
United States	Research Site	Bristol	Tennessee
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbia	South Carolina
United States	Research Site	Coral Gables	Florida
United States	Research Site	Council Bluffs	Iowa
United States	Research Site	Crestview Hills	Kentucky
United States	Research Site	Dallas	Texas
United States	Research Site	Golden	Colorado
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Beach	California
United States	Research Site	Huntington Park	California
United States	Research Site	Kenosha	Wisconsin
United States	Research Site	Kissimmee	Florida
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Lomita	California
United States	Research Site	Los Angeles	California
United States	Research Site	Manassas	Virginia
United States	Research Site	Mesa	Arizona
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami Beach	Florida
United States	Research Site	Morehead City	North Carolina
United States	Research Site	Norman	Oklahoma
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Northridge	California
United States	Research Site	Norwalk	California
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Paramount	California
United States	Research Site	Pasadena	Texas
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Phoenix	Arizona
United States	Research Site	Sacramento	California
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	Suffolk	Virginia
United States	Research Site	Tarzana	California
United States	Research Site	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Hungary,  Mexico,  Poland,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in HbA1c		Baseline (randomization) to Week 26
Secondary	Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%		week 26
Secondary	Mean Change in Total Body Weight		Baseline (randomization) to Week 26
Secondary	Mean Change in Fasting Plasma Glucose (FPG)		Baseline (randomization) to Week 26

External Links

•   FDA Safety Alerts and Recalls