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A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before

NCT04760626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1085

Last updated 2025-09-03

Study results available
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Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

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

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

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 52 weeks.

DRUG

Insulin Glargine 100U/mL

Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

DRUG

Insulin Degludec

Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

DRUG

Insulin Glargine 300U/mL

Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-08-12
Completion
2022-08-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Greece
  • Hungary
  • Poland
  • Puerto Rico
  • Turkey (Türkiye)

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 NCT04760626 on ClinicalTrials.gov