A Phase 1 interventional study of SAR425899 in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
Primary Objectives:
Secondary Objectives:
Main study and 6-month study extension period:
To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:
Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).
Six-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.
Drug: SAR425899
Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
Drug: SAR425899
Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
Drug: SAR425899
Pharmaceutical form: Solution Route of administration: Subcutaneous
Frequency of gastrointestinal (GI) adverse events (AEs)
Relative frequency of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Frequency of GI AEs
Absolute frequency of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Frequency of GI AEs
Severity of GI AEs
Time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8
Change in body weight
Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Change in fasting plasma glucose (FPG)
Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Change in hemoglobin A1c (HbA1c)
Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Time frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Adverse events (AEs)
Number of AEs
Time frame: Main study: up to week 8; Six-month extension period: up to month 8
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
No publications or documents are linked to this record.
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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