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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 facts

Study ID: NCT04460885
Run by: Novo Nordisk A/S
People needed: 984
Starts: 2020-11-25
Expected to finish: 2022-12-01
Last updated by the study team: 2025-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female aged above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.
HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
Body mass index (BMI) equal to or below 40.0 kg/m\^2.

You may not qualify if…

Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
Chronic heart failure classified as being in New York Heart Association Class IV at screening.
Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Where it is running

Lakeview Clinical Research, LLC — Guntersville, Alabama, United States
Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
Anaheim Clinical Trials — Anaheim, California, United States
Advanced Clinical Research/Rancho Paseo Medical Group — Banning, California, United States
American Clinical Trials — Buena Park, California, United States
San Fernando Valley Hlth Inst, LLC — Canoga Park, California, United States
Med Center Medical Clinic — Carmichael, California, United States
Headlands Research California, LLC — Escondido, California, United States
Valley Research — Fresno, California, United States
Scripps Whittier Diabetes Inst — La Jolla, California, United States
First Valley Medical Group — Lancaster, California, United States
Clinical Trials Research_Sacramento — Lincoln, California, United States
Torrance Clin Res Inst, Inc. — Lomita, California, United States
Providence Clinical Research — North Hollywood, California, United States
Valley Clinical Trials, Inc. — Northridge, California, United States
Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
NorCal Endocrinology and Internal Medicine_Roseville — Roseville, California, United States
Diabetes Research Center — Tustin, California, United States
Coastal Metabolic Research Center — Ventura, California, United States
Denver Endocrinology Diabetes and Thyroid Center — Englewood, Colorado, United States
Chase Medical Research LLC — Waterbury, Connecticut, United States
Revival Research — Doral, Florida, United States
East Coast Institute for Research, LLC — Jacksonville, Florida, United States
Jacksonville Ctr For Clin Res — Jacksonville, Florida, United States
Uni of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.