A Phase 3 interventional study of Efpeglenatide (SAR439977) and Placebo in Type 2 Diabetes Mellitus, sponsored by Sanofi. Terminated at 353 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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Among 186 studies in Diabetes Mellitus, Type 2 by Sanofi — 1 open to participants now, 1 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Sanofi.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, this one is the 4th largest by enrollment of the 178 interventional ones that give a count, is one of 12 that started in 2018, is one of 80 in phase 3, and was the 162nd registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →1 of the 186 studies in Diabetes Mellitus, Type 2 by Sanofi is open now, in 1 country. Recruiting first, the newest first:
Sanofi · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
186 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4,076 is above the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 334 across the 178 interventional studies, 1,229 across the 5 observational. Of the 183 that completed or were terminated, 46 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Primary Objective:
To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
Secondary Objectives:
To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:
To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
The study duration per participant was up to approximately 36 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.
Drug: Placebo
Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.
Drug: Efpeglenatide (SAR439977)
Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
Drug: Efpeglenatide (SAR439977)
Pharmaceutical form: Solution for injection, Route of administration: SC
Pharmaceutical form: Solution for injection Route of administration: SC
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis
All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time frame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis
All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time frame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event
All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
Time frame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint
Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (\>) 300, as measured in mg of albumin to grams of creatinine, or \>33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m\^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time frame: From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)
The study was conducted at 344 active sites in 28 countries. Overall, 5732 participants were screened between 27 April 2018 and 25 April 2019; of whom 4076 participants were randomized by interactive response technology (1:1:1 ratio) to receive placebo, efpeglenatide 4 milligrams (mg) or efpeglenatide 6 mg. Screen failures were mainly due to inclusion criteria not met.
| Milestone | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg |
|---|---|---|---|
| Started | 1359 | 1359 | 1358 |
| Randomized and treated | 1358 | 1358 | 1357 |
| Safety population | 1355 | 1360 | 1358 |
| Completed | 42 | 36 | 23 |
| Not completed | 1317 | 1323 | 1335 |
| Withdrew: Adverse event | 49 | 68 | 79 |
| Withdrew: Study terminated by sponsor | 1050 | 1063 | 1071 |
| Withdrew: Physician decision (other than adverse event) | 12 | 17 | 10 |
| Withdrew: Withdrawal by subject | 176 | 154 | 151 |
| Withdrew: Other | 29 | 20 | 23 |
| Withdrew: Randomized and not treated | 1 | 1 | 1 |
All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
| events per 100 participant-years | Efpeglenatide 4 mg+6 mg | Placebo |
|---|---|---|
| Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis | 3.9 (3.4 to 4.5) | 5.3 (4.4 to 6.3) |
All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
| events per 100 participant-years | Efpeglenatide 4 mg+6 mg | Placebo |
|---|---|---|
| Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis | 3.9 (3.4 to 4.5) | 5.3 (4.4 to 6.3) |
All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
| events per 100 participant-years | Efpeglenatide 4 mg+6 mg | Placebo |
|---|---|---|
| Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event | 5.4 | 6.8 |
Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (\>) 300, as measured in mg of albumin to grams of creatinine, or \>33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m\^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
| events per 100 participant-years | Efpeglenatide 4 mg+6 mg | Placebo |
|---|---|---|
| Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint | 7.7 (6.9 to 8.6) | 11.6 (10.2 to 13.1) |
Collected over From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 49/1,355 (3.6%) | 298/1,355 (22%) | 151/1,355 (11.1%) |
| Efpeglenatide 4 mg | 40/1,360 (2.9%) | 312/1,360 (22.9%) | 348/1,360 (25.6%) |
| Efpeglenatide 6 mg | 25/1,358 (1.8%) | 275/1,358 (20.3%) | 342/1,358 (25.2%) |
| Event | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg |
|---|---|---|---|
| Angina UnstableCardiac disorders | 23/1355 | 20/1360 | 10/1358 |
| Angina PectorisCardiac disorders | 10/1355 | 8/1360 | 17/1358 |
| PneumoniaInfections and infestations | 15/1355 | 14/1360 | 9/1358 |
| Atrial FibrillationCardiac disorders | 12/1355 | 15/1360 | 12/1358 |
| Coronary Artery DiseaseCardiac disorders | 10/1355 | 14/1360 | 5/1358 |
| Cardiac FailureCardiac disorders | 12/1355 | 4/1360 | 1/1358 |
| Acute Kidney InjuryRenal and urinary disorders | 9/1355 | 10/1360 | 10/1358 |
| Peripheral Arterial Occlusive DiseaseVascular disorders | 8/1355 | 7/1360 | 10/1358 |
| Myocardial InfarctionCardiac disorders | 9/1355 | 4/1360 | 6/1358 |
| SepsisInfections and infestations | 9/1355 | 4/1360 | 4/1358 |
| Event | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 51/1355 | 196/1360 | 167/1358 |
| DiarrhoeaGastrointestinal disorders | 64/1355 | 116/1360 | 117/1358 |
| VomitingGastrointestinal disorders | 18/1355 | 85/1360 | 75/1358 |
| Decreased AppetiteMetabolism and nutrition disorders | 15/1355 | 68/1360 | 77/1358 |
| HypoglycaemiaMetabolism and nutrition disorders | 37/1355 | 73/1360 | 53/1358 |
Analysis was performed on Intent-to-treat (ITT) population that included all randomized participants irrespective of compliance with the study protocol and procedures and were analyzed in the treatment group to which they were randomized.
| Age, Continuous(years) | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Total |
|---|---|---|---|---|
| Mean | 64.4 ± 8.3 | 64.6 ± 8.2 | 64.7 ± 8.2 | 64.5 ± 8.2 |
| Sex: Female, Male(Participants) | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Total |
|---|---|---|---|---|
| Female | 419 | 442 | 483 | 1344 |
| Male | 940 | 917 | 875 | 2732 |
| Race (NIH/OMB)(Participants) | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 11 | 8 | 8 | 27 |
| Asian | 98 | 87 | 82 | 267 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 2 | 3 |
| Black or African American | 50 | 38 | 55 | 143 |
| White | 1162 | 1192 | 1180 | 3534 |
| More than one race | 4 | 9 | 5 | 18 |
| Unknown or Not Reported | 34 | 24 | 26 | 84 |
| Body Mass Index (BMI)(kilogram meter per square (kg/m^2)) | Placebo | Efpeglenatide 4 mg | Efpeglenatide 6 mg | Total |
|---|---|---|---|---|
| Mean | 32.40 ± 6.01 | 32.81 ± 6.22 | 32.90 ± 6.21 | 32.70 ± 6.15 |
Showing the first 100 of 353 sites across 28 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.
Ran from Apr 2018 to primary completion in Dec 2020, 31 months.
Results were first posted in Oct 2021, 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efpeglenatide