Clinical trial NCT02551874: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 650
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 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.

Detailed description: CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

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

Inclusion Criteria:

* 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) \&lt; 60 ml/ml/1.73m2
* Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change From Baseline in HbA1c at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Total Body Weight at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Subjects With Confirmed Hypoglycaemia at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Mean Value of 24-hour Glucose at Week 2
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Norcross
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Quincy
country: United States
facility: Research Site
state: Massachusetts
city: Beavercreek
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Barto
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Kingsport
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Bountiful
country: United States
facility: Research Site
state: Utah
city: Karlovy Vary
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Koebenhavn
country: Denmark
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: Guadalajara
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Zapopan, Jalisco
country: Mexico
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Nowy Duninow
country: Poland
facility: Research Site
city: Sochaczew
country: Poland
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Timișoara
country: Romania
facility: Research Site
city: Lenasia
country: South Africa
facility: Research Site
city: La Coruña
country: Spain
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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.