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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 facts

Study ID

NCT04760626

Run by

Novo Nordisk A/S

People needed

1085

Starts

2021-03-01

Expected to finish

2022-08-29

Last updated by the study team

2026-06-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
• HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
• 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) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists.
• Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

You may not qualify if…

• Known or suspected hypersensitivity to trial product(s) or related products.
• Previous participation in this trial. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
• Any disorder which in the investigator's opinion might jeopardise subject's safety.

Where it is running

• Lakeview Clinical Research, LLC — Guntersville, Alabama, United States
• Pri Med Grp dba/Gil Ctr Fam — Gilbert, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Anaheim Clinical Trials, LLC — 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
• Advanced Investigative Medicine, Inc. — Hawthorne, California, United States
• Diabetes/Lipid Mgmt & Res Ctr — Huntington Beach, California, United States
• Altman Clin & Trans Res Inst — La Jolla, 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
• Adventist Health White Memorial — Los Angeles, 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
• San Diego Family Care — San Diego, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• Encompass Clinical Research_Spring Valley — Spring Valley, California, United States
• Univ of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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