NCT03751657

A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe). The study doctors will test insulin 287 to see how well it works compared to insulin glargine. The study will also test if insulin 287 is safe. The study participants will either get insulin 287 or insulin glargine (100 units/mL) - which treatment the participants get is decided by chance. The participants will need to inject their selves every day about the same time. Once a week the participant will need to take 1 extra injection on the same day of the week. The participants will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter using a finger prick, 2) write down different information in a paper diary daily and return this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2 weeks 5 times during the study.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin icodec	Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)
DRUG	Placebo (insulin 287)	Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.
DRUG	Metformin	Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.
DRUG	Dipeptidyl peptidase-4 inhibitors	Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.
DRUG	Insulin glargine	Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).
DRUG	Placebo (insulin glargine)	Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.

Timeline

• Start date: 2018-11-29
• Primary completion: 2019-12-16
• Completion: 2020-01-17
• First posted: 2018-11-23
• Last updated: 2021-04-02
• Results posted: 2021-02-01

Locations

49 sites across 7 countries: United States, Canada, Czechia, Greece, Poland, Slovakia, Slovenia

Regulatory

• FDA-regulated drug study