Clinical trial NCT03687827: A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
Official title: A Randomised, Cross-over, Open-label, Multi-centre Trial Comparing the Effect of Insulin Degludec and Insulin Glargine 100U/mL, With or Without OADs in Subjects With Type 2 Diabetes Using Flash Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 498
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 study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chance. Both medicines are approved for use in humans and available on the market. They can already be prescribed by participants' doctors. Participants will get pre-filled insulin pens to inject these insulins with. The study will last for about 41 weeks. Participants will visit the clinic 13 times and have 27 phone calls with the study doctor or study staff. At 12 of the clinic visits they will take blood samples. In order to evaluate the changes in participants' blood sugar level over time, participants will be asked to wear a small (35 millimetres (mm) x 5 mm) sensor on the back of participants' upper arm 3 times during the study. Each time participants must wear the sensor for 2 weeks. This sensor is called FreeStyle Libre Pro®. It has a very small tip which is 0.4 mm thick and is inserted 5 mm under participants' skin. Please note that participants will not be able to see the sensor readings while wearing it. The study doctor will show participants the readings when participants return to the clinic. Participants will be asked to fill in a diary in between visits. Participants will have contact with the study doctor or study staff each week. This is to adjust the dose of participants' study medicines and to ensure that participants are well. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
* Subjects fulfilling at least one of the below criteria:
* Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018)\*
* Moderate renal impairment defined as estimated glomerular filtration rate value of 30-59 mL/min/1.73 m\^2 as defined by Kidney Disease Improving Global Outcomes 2012 at screening
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 at screening
* Treated with insulin for more than 5 years
* Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or less, i.e., Level 1) within the last 12 weeks prior to screening visit
* Treated with any basal insulin greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs:
* Metformin
* Dipeptidyl peptidase-4 inhibitor
* Sodium-glucose co-transporter 2 inhibitor
* Alpha-glucosidase-inhibitors (acarbose)
* Thiazolidinediones
* Marketed oral combination products only including the products listed above
* HbA1c less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central laboratory analysis
* Body mass index less than or equal to 45 kg/m\^2 \*Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, intermittent bolus insulin treatment for periods of no longer than 14 days are permitted prior to the day of screening
* Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids)
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and run-in

Primary outcomes:
measure: Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)
timeFrame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)
Secondary outcomes:
measure: Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring
timeFrame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
measure: Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring
timeFrame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
measure: Level of Glycated Haemoglobin (HbA1c) - Percentage
timeFrame: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
measure: Level of Glycated Haemoglobin (HbA1c) - mmol/Mol
timeFrame: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
measure: Mean Glucose Levels Using Flash Glucose Monitoring (FGM)
timeFrame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Northridge
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Poway
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Van Nuys
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hamden
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Bradenton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Cooper City
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hollywood
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: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
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: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kalispell
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: New Windsor
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Pelzer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Dakota Dunes
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Kerrville
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: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Concord
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bytca
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Levice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Malacky
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nove Zamky
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Trebisov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Trnava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Zilina
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Port Elizabeth
country: South Africa
facility: Novo Nordisk Investigational Site
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Goldenberg RM, Aroda VR, Billings LK, Christiansen ASL, Meller Donatsky A, Parvaresh Rizi E, Podgorski G, Raslova K, Klonoff DC, Bergenstal RM. Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia. Diabetes Obes Metab. 2021 Nov;23(11):2572-2581. doi: 10.1111/dom.14504. Epub 2021 Aug 16.