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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 498 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-12-20
• Completion: 2019-12-27
• First posted: 2018-09-27
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

67 sites across 6 countries: United States, Canada, Poland, Puerto Rico, Slovakia, South Africa

Regulatory

• FDA-regulated drug study