A Phase 1 interventional study of SAR425899 and [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Basic science
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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 170th largest by enrollment of the 178 interventional ones that give a count, is one of 6 that started in 2017, is one of 16 in phase 1, and was the 155th 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 to 75 Years · all sexes · no healthy volunteers.
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186 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below 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.
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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 Objectives:
To assess in overweight to obese T2DM patients:
Study duration is approximately 7 weeks with a 20 days treatment period.
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 is not intended to contain all considerations relevant to a patient'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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days
Drug: SAR425899 · Drug: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) · Drug: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Repeated once daily SC doses of SAR425899 administered over 20 days
Drug: SAR425899 · Drug: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) · Drug: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Glucagon receptor occupancy
Change of glucagon receptor tracer binding in the liver with SAR425899 between Day 1 and Day 20
Time frame: Day 1 and Day 20
GLP-1 receptor occupancy
Change of GLP-1 receptor tracer binding in the pancreas with SAR425899 between Day 1 and Day 17
Time frame: Day 1 and Day 17
Adverse events
Number of adverse events in patients under treatment with SAR425899
Time frame: Up to 27 days
Pharmacokinetics
Assessment of SAR425899 maximum plasma concentration (Cmax)
Time frame: Day 20
Change in fasting plasma glucose (FPG)
Absolute change in FPG from baseline to Day 20
Time frame: Day 1 to Day 20
Change in ketone bodies
Absolute change in ketone bodies from baseline to Day 20
Time frame: Day 1 to Day 20
Change lipid biomarkers
Absolute change cholesterol from baseline to Day 20
Time frame: Day 1 to Day 20
Change in volume of distribution (Vt) in the liver
Change of glucagon receptor tracer Vt in the liver with SAR425899 between Day 1 and Day 20
Time frame: Day 1 and Day 20
Change in Vt in the pancreas
Change of GLP-1 receptor tracer Vt in the pancreas with SAR425899 between Day 1 and Day 17
Time frame: Day 1 and Day 17
Average standard uptake values (SUVs) of PET tracers in the liver and pancreas
Average SUVs for glucagon and GLP-1 tracer in liver and pancreas
Time frame: Day 1, Day 17 and Day 20
Pharmacokinetics
Assessment of SAR425899 time to reach Cmax ( tmax)
Time frame: Day 20
Pharmacokinetics
Assessment of SAR425899 area under the concentration versus time curve (AUC)
Time frame: Day 20
Pharmacokinetics
Assessment of SAR425899 terminal elimination half-life ( t1/2)
Time frame: Day 20
Pharmacokinetics
Assessment of SAR425899 total body clearance from the plasma (CL)
Time frame: Day 20
Change lipid biomarkers
Absolute change in free fatty acids from baseline to Day 20
Time frame: Day 1 to Day 20
Change lipid biomarkers
Absolute change in triglycerides from baseline to Day 20
Time frame: Day 1 to Day 20
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Dec 2017 to primary completion in Jun 2018, 5 months.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 5 months is close to that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: SAR425899 · Gallium-68