Clinical trial NCT02030600: A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes
Official title: A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 721
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m\^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL \[below or equal to 3.9 mmol/L\])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m\^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

Primary outcomes:
measure: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
timeFrame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Secondary outcomes:
measure: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period
timeFrame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
measure: Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period
timeFrame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: During 32 weeks of treatment for each treatment period
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 32, Week 64
measure: FPG (Fasting Plasma Glucose)
timeFrame: week 32, week 64
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Haleyville
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tuscumbia
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Costa Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Downey
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: El Cajon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hawaiian Gardens
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Huntington Park
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lincoln
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Montclair
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: North Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Pomona
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Poway
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Rialto
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Roseville
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Monica
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tarzana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Torrance
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tustin
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Newark
country: United States
facility: Novo Nordisk Investigational Site
state: Delaware
city: Bradenton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chiefland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Cooper City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Doral
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miramar
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Panama City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Perry
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Champaign
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Muncie
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: West Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Lenexa
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Newton
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Paducah
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Brockton
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Florissant
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Newington
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Morganville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Teaneck
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novo Nordisk Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Jackson Heights
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New Windsor
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Northport
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Smithtown
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Morganton
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Delaware
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Franklin
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Altoona
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Beaver
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Scottdale
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Pelzer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Humboldt
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Carrollton
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: El Paso
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Humble
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Marshall
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Richardson
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sealy
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Victoria
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Waco
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Draper
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Richland
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Spokane
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Martinsburg
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
city: Kenosha
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Carolina
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: San Juan
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: San Juan
country: Puerto Rico
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft SH, Philis-Tsimikas A. Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clin Diabetes. 2019 Jan;37(1):73-81. doi: 10.2337/cd18-0016.
citation: Wysham C, Bhargava A, Chaykin L, de la Rosa R, Handelsman Y, Troelsen LN, Kvist K, Norwood P. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):45-56. doi: 10.1001/jama.2017.7117.
citation: Evans M, Mehta R, Gundgaard J, Chubb B. Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting. Diabetes Ther. 2018 Oct;9(5):1919-1930. doi: 10.1007/s13300-018-0478-1. Epub 2018 Aug 10.
citation: DeVries JH, Bailey TS, Bhargava A, Gerety G, Gumprecht J, Heller S, Lane W, Wysham CH, Zinman B, Bak BA, Hachmann-Nielsen E, Philis-Tsimikas A. Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials. Diabetes Obes Metab. 2019 Mar;21(3):622-630. doi: 10.1111/dom.13565. Epub 2018 Nov 26.
citation: Heller SR, DeVries JH, Wysham C, Hansen CT, Hansen MV, Frier BM. Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2. Diabetes Obes Metab. 2019 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.