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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin icodec — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
• Insulin Glargine 100U/mL — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
• Insulin Degludec — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
• Insulin Glargine 300U/mL — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Study Details

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.

Key Dates

Start date

Mar 1, 2021

Status verified

Aug 2025

Primary completion

Aug 12, 2022

Completion

Aug 29, 2022

Study Design

Enrollment

1,085 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin icodec with DoseGuide
  Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
• Active Comparator: Once daily basal insulin analogues
  Participants randomised to basal insulin analogue injections once daily

Primary Outcome Measure

Change in Glycated Haemoglobin (HbA1c) [ Time Frame: Baseline (week 0), week 52 ]

Locations (79)

Related coverage on Hipa.ai

• Insulin Icodec Shows Greater HbA1c Reduction in Type 2 Diabetes Trial
  Liraglutide · Aug 26, 2025 · ClinicalTrials.gov

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