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COMPLETED Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Insulin Icodec

Study Locations (20)

Texas

  • Amarillo Medical Specialists — Amarillo
  • Velocity Clin Res, Dallas — Dallas
  • UT Southwestern Med Cntr — Dallas
  • Fmc Science, Llc — Lampasas
  • Clinical Trials of Texas Inc — San Antonio
  • Northeast Clinical Research of San Antonio — San Antonio

California

  • Desert Oasis Hlthcr Med Group — Palm Springs
  • Clinical Trials Research_Sacramento_0 — Sacramento
  • San Diego Family Care — San Diego
  • Mills-Peninsula Hlth Services — San Mateo

Florida

  • Florida Inst For Clin Res LLC — Orlando
  • Metabolic Research Institute Inc — West Palm Beach

Hawaii

  • East West Med Res Inst — Honolulu

Michigan

  • Northern Pines Hlth Ctr, PC — Buckley

Minnesota

  • International Diabetes Center — Minneapolis

Nevada

  • Palm Research Center Inc-Vegas — Las Vegas

North Carolina

  • Accellacare_NC — Wilmington

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2023-04-11
Est. Completion 2024-04-11
Phase Phase 3

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05823948

The ClinicalTrials.gov registry entry for NCT05823948 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention — of which Insulin Icodec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05823948 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05823948 about?

NCT05823948 is a clinical study titled "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...

What is the current status of trial NCT05823948?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2023-04-11. Estimated completion is 2024-04-11.

What conditions does trial NCT05823948 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05823948?

The interventions under investigation include: Insulin Icodec (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05823948?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05823948 being conducted?

This trial has 20 study locations across California, Florida, Hawaii, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial