A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin degludec — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks
• Insulin Icodec — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

Study Details

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (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 degludec 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 degludec 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 8 months. Participants will have 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 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 their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Key Dates

Start date

Mar 5, 2021

Status verified

Nov 2025

Primary completion

Jan 27, 2022

Completion

Mar 1, 2022

Study Design

Enrollment

526 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin icodec
  Insulin icodec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.
• Active Comparator: Insulin degludec
  Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.

Primary Outcome Measure

Change in Glycated Haemoglobin (HbA1c) [ Time Frame: Baseline (Week 0), Week 26 ]

Locations (38)

Related coverage on Hipa.ai

• Liraglutide Alias Insulin Degludec Compared to Icodec in T2D Trial
  Liraglutide · Feb 20, 2025 · ClinicalTrials.gov

Find similar trials in Buena Park, CA

Related Studies

• Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
  Recruiting · The University of Texas Health Science Center at San Antonio · San Antonio, Texas
• Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.
  PHASE2 · Enrolling By Invitation · Columbia University · New York, New York
• Use of CGM in Kidney Transplant Recipients
  Recruiting · University of California, Davis · Sacramento, California
• Food as Medicine for HIV and Diabetes
  Recruiting · University of North Carolina, Chapel Hill · Chapel Hill, North Carolina