NCT03922750

A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine

A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin icodec	Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
DRUG	Insulin glargine U100	Participants will receive s.c. injections of insulin glargine OD for 16 weeks

Timeline

• Start date: 2019-05-09
• Primary completion: 2019-12-19
• Completion: 2020-01-27
• First posted: 2019-04-22
• Last updated: 2022-01-18
• Results posted: 2021-01-08

Locations

38 sites across 5 countries: United States, Canada, Czechia, Germany, Italy

Regulatory

• FDA-regulated drug study