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Completed

NCT Number: NCT05823948

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Desert Oasis Hlthcr Med Group, Palm Springs, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Insulin icodec

Drug

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

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Baseline (week 0), week 26

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes

Acronym: ONWARDS 9

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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