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NCT03819153 · ClinicalTrials.gov registry record · Phase 3
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,533
- Enrollment target
- 20
- Study locations
NCT03819153: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
NCT03819153 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 3,533 participants, below the 4,475-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03819153, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,533 participants
- Enrollment target
- 20
- Study locations
Study Summary
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.
Primary Outcome
Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration \[CKD-EPI\]), onset of persistent eGFR (CKD-EPI) \<15 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal de
Conditions Studied
Interventions
- DRUG Semaglutide
- DRUG Placebo (semaglutide)
Study Locations (20)
California
- California Inst Of Renal Res - Chula Vista
- John Muir Physician Network - Concord
- John Muir Physicians Network - Concord
- Valley Research - Fresno
- California Institute of Renal Research - La Mesa
- First Valley Med Grp Lancaster - Lancaster
- Clinical Trials Research_Sacramento - Lincoln
- VA Loma Linda Hlthcr Sys - Loma Linda
- Long Beach Center For Clinical Research - Long Beach
- VA Long Beach Healthcare System - Long Beach
- Academic Medical Research Institute - Los Angeles
- Valley Renal Medical Group Research - Northridge
- Desert Oasis Hlthcr Med Group - Palm Springs
- Saviers Medical Group - Port Hueneme
- Inland Empire Clin Trials LLC - Rialto
- Sierra Clinical Research - Roseville
- California Research Foundation - San Diego
- N America Res Inst - San Dimas - San Dimas
- NorCal Endocrinology and Internal Medicine - San Ramon
Alabama
- Dr. Terence Hart - Tuscumbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,533 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2024-01-09 |
| Phase | Phase 3 |
What the finished NCT03819153 record still lists
NCT03819153 is an interventional study that assigns participants to a tested intervention. Its 3,533 participants enrollment target places it among the larger protocols in the corpus, below the 4,475-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide is the first listed.
NCT03819153 names 20 study sites across 2 states, led by California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03819153 about?
NCT03819153 is a clinical study titled "A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease". The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatme...
What is the current status of trial NCT03819153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,533 participants. The study started on 2019-06-17. Estimated completion is 2024-01-09.
What conditions does trial NCT03819153 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03819153?
The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).
Who is sponsoring clinical trial NCT03819153?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03819153 being conducted?
This trial has 20 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03819153's enrollment target sits among peer trials
3,533 17th of 348 higher than 332 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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