CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 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/NCT03951805
NCT03951805Phase 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 Insulin-naïve Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted May 15, 2019·Updated Apr 5, 2021

In Brief

A Phase 2 clinical trial evaluating Insulin icodec and Insulin Glargine for Diabetes Mellitus, Type 2. Completed, enrolled 205 participants across 43 sites in 7 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 changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Participants will either get insulin 287 that they will have to inject once a week or insulin glargine that participants will have to inject once a day. Which treatment participants get is decided by chance. The study will last for about 5 months (23 weeks). 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 study doctor will ask participants to: * measure blood sugar every day with a blood sugar meter using a finger prick. * write down different information in a diary daily and return this to the study doctor. * wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about 4 months) during the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia, Germany, Hungary, Poland, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 15, 2019
Enrollment StartMay 9, 2019
Primary CompletionDec 12, 2019
Study CompletionJan 17, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.1 years ago

Interventions

Insulin icodecdrug

Administered subcutaneously SC once weekly. Starting dose will be 70U.

Insulin Glarginedrug

Administered subcutaneously SC once daily.The starting dose will be 10U.