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NCT04795531 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 588
- Enrollment target
- 20
- Study locations
NCT04795531 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 588 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT04795531, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 588 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 588 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2022-06-23 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 588 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (87% 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 4 interventions - of which Insulin icodec is the first listed.
NCT04795531 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Ohio.
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.
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).
Who is sponsoring clinical trial NCT04795531?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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