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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin icodec — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
• Insulin glargine — DRUG
  Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

Study Details

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.

Key Dates

First listed

Jul 8, 2020

Start date

Nov 25, 2020

Status verified

Nov 2025

Primary completion

May 29, 2022

Completion

Dec 1, 2022

Study Design

Enrollment

984 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin icodec
  Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
• Active Comparator: Insulin glargine
  Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic 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 52 ]

Locations (97)

Find similar trials in Birmingham, AL

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
• Blood Markers of Early Pancreas Cancer
  Recruiting · University of Nebraska · Omaha, Nebraska
• Phenotyping Genetic Risk for Type 2 Diabetes
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania