Trial · NCT03819153
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
NCT03819153, Phase 3, Completed, Novo Nordisk A/S; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease. Trials, record NCT03819153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03819153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
- NCT number
- NCT03819153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,533 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Semaglutide, Placebo (semaglutide)
- First posted
- 2019-01-28
- Last updated
- 2025-03-20
- Other registries' IDs
- eudract:2018-002878-50
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | From Week 0 up to Week 234 | 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 death, and cardiovascular (CV) death combined data were reported in this outcome measure. |
| Secondary | Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) | From Week 0 up to Week 234 | Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | From Week 0 up to Week 234 | Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | From Week 0 up to Week 234 | Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) \<15 mL/min/1.73m\^2 were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | From Week 0 up to Week 234 | Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Number of Participants From Time of Randomization to Occurrence of Renal Death | From Week 0 up to Week 234 | Number of participants from time of randomization to time to occurrence of renal death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Number of Participants From Time of Randomization to Occurrence of CV Death | From Week 0 up to Week 234 | Number of participants from time of randomization to time to occurrence of CV death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope) | Week 12, Week 234 | Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Change From Baseline in eGFR (CKD-EPI) at Week 12 | Baseline (Week 0), Week 12 | Change from baseline in eGFR at Week 12 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
| Secondary | Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104 | Baseline (Week 0), Week 104 | Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported. Cystatin C was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | (mL/min/1.73 m^2)/year | MEAN |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of Renal Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants From Time of Randomization to Occurrence of CV Death | From Week 0 up to Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope) | Week 12, Week 234 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Change From Baseline in eGFR (CKD-EPI) at Week 12 | Baseline (Week 0), Week 12 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104 | Baseline (Week 0), Week 104 | FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | mL/min/1.73m^2 | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | Semaglutide | 331 | Participants | ||
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | Placebo | 410 | Participants | ||
| Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) | Semaglutide | -2.19 | Standard Error 0.1 | (mL/min/1.73 m^2)/year | |
| Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope) | Placebo | -3.36 | Standard Error 0.1 | (mL/min/1.73 m^2)/year | |
| Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | Semaglutide | 165 | Participants | ||
| Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | Placebo | 213 | Participants | ||
| Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | Semaglutide | 92 | Participants | ||
| Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | Placebo | 110 | Participants | ||
| Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | Semaglutide | 87 | Participants | ||
| Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | Placebo | 100 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 1,767 | |
| Overall Study | STARTED | Placebo | 1,766 | |
| Overall Study | Full Analysis Set (FAS) | Semaglutide | 1,767 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 1,766 | |
| Overall Study | COMPLETED | Semaglutide | 1,724 | |
| Overall Study | COMPLETED | Placebo | 1,708 | |
| Overall Study | NOT COMPLETED | Semaglutide | 43 | |
| Overall Study | NOT COMPLETED | Placebo | 58 |
Source ClinicalTrials.gov
Adverse events2,046
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Semaglutide | 221 | 1,767 | 238 |
| other | COVID-19 | Infections and infestations | Placebo | 246 | 1,766 | 260 |
| other | Diabetic retinopathy | Eye disorders | Semaglutide | 339 | 1,767 | 394 |
| other | Diabetic retinopathy | Eye disorders | Placebo | 325 | 1,766 | 381 |
| serious | Abdominal distension | Gastrointestinal disorders | Semaglutide | 1 | 1,767 | 1 |
| serious | Abdominal distension | Gastrointestinal disorders | Placebo | 2 | 1,766 | 2 |
| serious | Abdominal hernia | Gastrointestinal disorders | Semaglutide | 1 | 1,767 | 1 |
| serious | Abdominal hernia | Gastrointestinal disorders | Placebo | 1 | 1,766 | 1 |
| serious | Abdominal hernia obstructive | Gastrointestinal disorders | Semaglutide | 0 | 1,767 | 0 |
| serious | Abdominal hernia obstructive | Gastrointestinal disorders | Placebo | 1 | 1,766 | 1 |
1 to 10 of 2,046Source ClinicalTrials.gov
See all 2,046 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 227 | 1,767 |
| Total, all-cause mortality | Placebo | 279 | 1,766 |
| Total, other adverse events | Semaglutide | 507 | 1,767 |
| Total, other adverse events | Placebo | 522 | 1,766 |
| Total, serious adverse events | Semaglutide | 877 | 1,767 |
| Total, serious adverse events | Placebo | 950 | 1,766 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy | Trial comparisons |
Semaglutide vs Placebo: Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death | Trial comparisons |
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Occurrence of CV Death | Trial comparisons |
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI) | Trial comparisons |
Semaglutide vs Placebo: Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization | Trial comparisons |
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Occurrence of Renal Death | Trial comparisons |
Semaglutide vs Placebo: Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction | Trial comparisons |
Semaglutide vs Placebo: Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death | Trial comparisons |
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2 | Trial comparisons |
| Semaglutide vs Placebo: Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03819153
GET https://conductscience.org/api/trials/v1/NCT03819153/registered?page=2