CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Insulin icodec +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03922750
NCT03922750Phase 2Completed

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

Novo Nordisk A/S·interventional·Posted Apr 22, 2019·Updated Jan 18, 2022

In Brief

A Phase 2 clinical trial evaluating Insulin icodec and Insulin glargine U100 for Diabetes Mellitus, Type 2. Completed, enrolled 154 participants across 38 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Germany, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 22, 2019
Enrollment StartMay 9, 2019
Primary CompletionDec 19, 2019
Study CompletionJan 27, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.2 years ago

Interventions

Insulin icodecdrug

Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.

Insulin glargine U100drug

Participants will receive s.c. injections of insulin glargine OD for 16 weeks