A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)

NCT05823948 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: NN1436-4909U1111-1271-9296
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 20

Brief Summary

This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be 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 to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Haemoglobin (HbA1c)

  Change in HbA1c from week 0 to week 26 is presented in percentage-point.

  Baseline (week 0), week 26

Study Arms (1)

Insulin Icodec

EXPERIMENTAL

Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.

Drug: Insulin Icodec

Interventions

Insulin Icodec DRUG

Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen.

Insulin Icodec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
• Age above or equal to 18 years at the time of signing informed consent
• Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days before screening
• HbA1c from 7.0%-11.0% (53.0-96.7 millimoles per mole \[mmol/mol\]) both inclusive at screening confirmed by central laboratory analysis
• Insulin-naïve. However, short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes
• Stable daily dose(s) \>=90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
• Any metformin formulations \>= 1500 milligrams (mg) or maximum tolerated or effective dose or
• Any metformin combination formulations \>=1500 mg or maximum tolerated or effective dose or
• Other antidiabetic Drugs including combination products (\>=half of the maximum approved dose according to local label or maximum tolerated or effective dose) of the classes specified below: Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, Thiazolidinedione, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs, Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists
• Intensification with basal insulin is indicated to achieve fasting glycaemic target (4.4-7.2 millimoles per liter \[mmol/L\]; 80-130 milligrams per deciliter \[mg/dL\]) at the discretion of the treating investigator
• Body mass index (BMI) less than or equal to (\<=) 40.0 kilograms per meter square (kg/m\^2)

You may not qualify if:

• Unwilling or unable to avoid concomitant medication e.g., ascorbic acid (vitamin C) that can influence the flash glucose monitoring (FGM) sensor throughout the study and contraindications e.g., implanted medical devices such as pacemakers
• Any episodes of diabetic ketoacidosis within 90 days before screening as declared by the participant or in the medical records
• Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits
• Chronic heart failure classified as being in New York Heart Association (NYHA) 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 90 days before the day of screening or in the period between screening and initiation visits. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (20)

Desert Oasis Hlthcr Med Group

Palm Springs, California, 92262, United States

Location

Clinical Trials Research_Sacramento_0

Sacramento, California, 95821, United States

Location

San Diego Family Care

San Diego, California, 92111, United States

Location

Mills-Peninsula Hlth Services

San Mateo, California, 94401, United States

Location

Florida Inst For Clin Res LLC

Orlando, Florida, 32825, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89148, United States

Location

Accellacare_NC

Wilmington, North Carolina, 28401, United States

Location

Diabetes & Endocrinology Asso

Canton, Ohio, 44718, United States

Location

AM Diabetes And Endocrinology

Bartlett, Tennessee, 38133, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

Location

Velocity Clin Res, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Fmc Science, Llc

Lampasas, Texas, 76550, United States

Location

Clinical Trials of Texas Inc

San Antonio, Texas, 78229, United States

Location

Northeast Clinical Research of San Antonio

San Antonio, Texas, 78233, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Related Publications (1)

• Bergenstal RM, Asbjornsdottir B, Johanning Bari T, Hulkund S, Winhofer Y, Wysham C. Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial. Diabetes Technol Ther. 2025 Jul;27(7):527-536. doi: 10.1089/dia.2025.0050. Epub 2025 Mar 5.

  PMID: 40040516 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 21, 2023
• Study Start: April 11, 2023
• Primary Completion: March 6, 2024
• Study Completion: April 11, 2024
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (20)