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NCT05823948 · ClinicalTrials.gov registry record · 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)

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
51
Enrollment target
20
Study locations

NCT05823948 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 51 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05823948, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
51 participants
Enrollment target
20
Study locations

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

431 total trials

What the Registry Record Tells You About NCT05823948

The ClinicalTrials.gov registry entry for NCT05823948 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

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.

NCT05823948 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Florida.

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.

What interventions are being tested in trial NCT05823948?

The interventions under investigation include: Insulin Icodec (DRUG).

Who is sponsoring clinical trial NCT05823948?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

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.

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

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