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A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

NCT04460885 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2025-12-04

Study results available
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Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin icodec

Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.

DRUG

Insulin glargine

Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2022-05-29
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States
  • Croatia
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460885 on ClinicalTrials.gov