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

Diabetes Mellitus, Type 2 Clinical Trial

— SWITCH PRO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687827
• Other study ID #: NN1250-4419
• Secondary ID: U1111-1203-05802
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: December 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: December 27, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin degludec
Participants will receive insulin degludec U100 subcutaneous (s.c.) injection once daily for 36 weeks. Doses will be adjusted according to the fasting self-measured plasma glucose (SMPG) values. Participants earlier treated with one or more allowed oral antidiabetic drug(s) (OAD(s)), should continue their pre-trial OAD(s) treatment throughout the trial.
• Insulin glargine
Participants will receive insulin glargine U100 s.c. injection once daily for 36 weeks. Doses will be adjusted according to the fasting SMPG values. Participants earlier treated with one or more allowed OAD(s), should continue their pre-trial OAD(s) treatment throughout the trial.

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Concord	Ontario
Canada	Novo Nordisk Investigational Site	Etobicoke	Ontario
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	Markham	Ontario
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Oakville	Ontario
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Victoria	British Columbia
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Warsaw
Puerto Rico	Novo Nordisk Investigational Site	Ponce
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bytca
Slovakia	Novo Nordisk Investigational Site	Levice
Slovakia	Novo Nordisk Investigational Site	Malacky
Slovakia	Novo Nordisk Investigational Site	Nove Mesto nad Vahom
Slovakia	Novo Nordisk Investigational Site	Nove Zamky
Slovakia	Novo Nordisk Investigational Site	Trebisov
Slovakia	Novo Nordisk Investigational Site	Trnava
Slovakia	Novo Nordisk Investigational Site	Zilina
South Africa	Novo Nordisk Investigational Site	Bloemfontein	Free State
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Lenasia	Gauteng
South Africa	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
United States	Novo Nordisk Investigational Site	Amarillo	Texas
United States	Novo Nordisk Investigational Site	Boston	Massachusetts
United States	Novo Nordisk Investigational Site	Boston	Massachusetts
United States	Novo Nordisk Investigational Site	Bradenton	Florida
United States	Novo Nordisk Investigational Site	Chandler	Arizona
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Cooper City	Florida
United States	Novo Nordisk Investigational Site	Dakota Dunes	South Dakota
United States	Novo Nordisk Investigational Site	Fresno	California
United States	Novo Nordisk Investigational Site	Greenville	North Carolina
United States	Novo Nordisk Investigational Site	Hamden	Connecticut
United States	Novo Nordisk Investigational Site	Hollywood	Florida
United States	Novo Nordisk Investigational Site	Kalispell	Montana
United States	Novo Nordisk Investigational Site	Kerrville	Texas
United States	Novo Nordisk Investigational Site	Lancaster	California
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Nashville	Tennessee
United States	Novo Nordisk Investigational Site	New Port Richey	Florida
United States	Novo Nordisk Investigational Site	New Windsor	New York
United States	Novo Nordisk Investigational Site	Northridge	California
United States	Novo Nordisk Investigational Site	Orlando	Florida
United States	Novo Nordisk Investigational Site	Pelzer	South Carolina
United States	Novo Nordisk Investigational Site	Pembroke Pines	Florida
United States	Novo Nordisk Investigational Site	Poway	California
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Skokie	Illinois
United States	Novo Nordisk Investigational Site	Statesville	North Carolina
United States	Novo Nordisk Investigational Site	Toledo	Ohio
United States	Novo Nordisk Investigational Site	Topeka	Kansas
United States	Novo Nordisk Investigational Site	Tucson	Arizona
United States	Novo Nordisk Investigational Site	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Puerto Rico,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter [mg/dL] (3.9-10.0 millimoles per litre [mmol/L]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)
Secondary	Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring	The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)).	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Secondary	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	Percentage of 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) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Secondary	Level of Glycated Haemoglobin (HbA1c) - Percentage	Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).	After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Secondary	Level of Glycated Haemoglobin (HbA1c) - mmol/Mol	Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).	After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Secondary	Mean Glucose Levels Using Flash Glucose Monitoring (FGM)	Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).