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NCT04460885 · 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 Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 984
- Enrollment target
- 20
- Study locations
NCT04460885 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 984 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT04460885, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 984 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (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 glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Conditions Studied
Interventions
- DRUG Insulin icodec
- DRUG Insulin glargine
Study Locations (20)
California
- Anaheim Clinical Trials - Anaheim
- Advanced Clinical Research/Rancho Paseo Medical Group - Banning
- American Clinical Trials - Buena Park
- San Fernando Valley Hlth Inst, LLC - Canoga Park
- Med Center Medical Clinic - Carmichael
- Headlands Research California, LLC - Escondido
- Valley Research - Fresno
- Scripps Whittier Diabetes Inst - La Jolla
- First Valley Medical Group - Lancaster
- Clinical Trials Research_Sacramento - Lincoln
- Torrance Clin Res Inst, Inc. - Lomita
- Providence Clinical Research - North Hollywood
- Valley Clinical Trials, Inc. - Northridge
- Desert Oasis Hlthcr Med Group - Palm Springs
- NorCal Endocrinology and Internal Medicine_Roseville - Roseville
- Diabetes Research Center - Tustin
- Coastal Metabolic Research Center - Ventura
Alabama
- Uni of Alabama at Birmingham - Birmingham
- Lakeview Clinical Research, LLC - Guntersville
Arkansas
- Lynn Institute of the Ozarks - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 984 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460885
The ClinicalTrials.gov registry entry for NCT04460885 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 984 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (78% 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 2 interventions - of which Insulin icodec is the first listed.
NCT04460885 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04460885 about?
NCT04460885 is a clinical study titled "A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before". This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (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 glargi...
What is the current status of trial NCT04460885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 984 participants. The study started on 2020-11-25. Estimated completion is 2022-12-01.
What conditions does trial NCT04460885 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT04460885?
The interventions under investigation include: Insulin icodec (DRUG), Insulin glargine (DRUG).
Who is sponsoring clinical trial NCT04460885?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460885 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California. 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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