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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551874
• Other study ID #: CV181-369
• Secondary ID: 2015-001702-33
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2015
• Est. completion date: November 10, 2017

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: November 10, 2017
• Est. primary completion date: May 8, 2017
• 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:

• 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) < 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Saxagliptin, Onglyza
Tablets, Oral, 5mg , Once daily, 24 weeks
• Dapagliflozin, Farxiga
Tablets, Oral, 10mg , Once daily, 24 weeks
• Glargine insulin
100 Units/ml solution for injection in a prefilled SoloStar pen
• Metformin
Tablets, Oral, = 1500mg/= 2500mg, Once daily, 24 weeks

Locations

Country	Name	City	State
Czechia	Research Site	Karlovy Vary
Czechia	Research Site	Olomouc
Denmark	Research Site	Koebenhavn
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Mexico	Research Site	Zapopan, Jalisco
Poland	Research Site	Lodz
Poland	Research Site	Nowy Duninow
Poland	Research Site	Sochaczew
Romania	Research Site	Craiova
Romania	Research Site	Ploiesti
Romania	Research Site	Timi?oara
Romania	Research Site	Timisoara
South Africa	Research Site	Lenasia
Spain	Research Site	La Coruña
Sweden	Research Site	Uddevalla
United States	Research Site	Anaheim	California
United States	Research Site	Barto	Pennsylvania
United States	Research Site	Beavercreek	Ohio
United States	Research Site	Bountiful	Utah
United States	Research Site	Bristol	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbia	South Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Norcross	Georgia
United States	Research Site	Norman	Oklahoma
United States	Research Site	Quincy	Massachusetts
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Hungary,  Mexico,  Poland,  Romania,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in HbA1c at Week 24	To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.	Baseline and Week 24
Secondary	Mean Change From Baseline in Total Body Weight at Week 24	To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment	Baseline and Week 24
Secondary	Percentage of Subjects With Confirmed Hypoglycaemia at Week 24	Hypoglycemia defined as plasma glucose =70 mg/dL (3.9 mmol/L)	Baseline and Week 24
Secondary	Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24	To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.	Baseline and Week 24
Secondary	Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24	To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.	Baseline and Week 24
Secondary	Change From Baseline in the Mean Value of 24-hour Glucose at Week 2	Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.	Baseline and Week 2

External Links

•   cv181-369 CSP redacted
•   cv181-369 SAP redacted
•   FDA Safety Alerts and Recalls