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COMPLETED Phase 3

A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

NCT04795531 · View on ClinicalTrials.gov ↗

Study Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get. The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions Studied

Interventions

  • DRUG Insulin icodec
  • DRUG Placebo insulin icodec
  • DRUG Insulin degludec
  • DRUG Placebo insulin degludec

Study Locations (20)

California

  • American Clinical Trials — Buena Park
  • Headlands Research California, LLC — Escondido
  • Valley Research — Fresno
  • First Valley Medical Group — Lancaster

Florida

  • Est Cst Inst for Rsrch,Jksnvil — Jacksonville
  • Palm Harbor Medical Associates — Palm Harbor
  • Metabolic Research Institute Inc — West Palm Beach

Ohio

  • Diab & Endo Assoc of Stark Co — Canton
  • Providence Health Partners Ctr — Dayton
  • Prestige Clinical Research — Franklin

North Carolina

  • Physician's East Endocrinology — Greenville
  • Accellacare — Wilmington

Alabama

  • Lakeview Clinical Research, LLC — Guntersville

Illinois

  • Cedar-Crosse Research Center — Chicago

Kansas

  • Cotton-Oneill Diabetes and End — Topeka

Michigan

  • Arcturus Healthcare, PLC — Troy

Trial Details

FieldValue
Enrollment Target 588 participants
Start Date 2021-03-24
Est. Completion 2022-06-23
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 NCT04795531

The ClinicalTrials.gov registry entry for NCT04795531 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 588 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 4 interventions — 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: NCT04795531 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Ohio. 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 NCT04795531 about?

NCT04795531 is a clinical study titled "A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)". This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin deglud...

What is the current status of trial NCT04795531?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 588 participants. The study started on 2021-03-24. Estimated completion is 2022-06-23.

What conditions does trial NCT04795531 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 NCT04795531?

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

Who is sponsoring clinical trial NCT04795531?

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 NCT04795531 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Kansas. 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