A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period
- Registration Number
- NCT03414736
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
* Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).
* Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.
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:
* The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).
* Safety and tolerability.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 SAR425899 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. Cohort 2 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. Cohort 3 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.
- Primary Outcome Measures
Name Time Method Frequency of gastrointestinal (GI) adverse events (AEs) Main study: Up to week 8; Six-month study extension period: Up to month 8 Relative frequency of GI AEs
Frequency of GI AEs Main study: Up to week 8; Six-month study extension period: Up to month 8 Severity of GI AEs
- Secondary Outcome Measures
Name Time Method Change in body weight Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Change in fasting plasma glucose (FPG) Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Change in hemoglobin A1c (HbA1c) Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.
Adverse events (AEs) Main study: up to week 8; Six-month extension period: up to month 8 Number of AEs
Trial Locations
- Locations (3)
Investigational Site Number 8400003
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 8400002
🇺🇸Saint Paul, Minnesota, United States
Investigational Site Number 8400001
🇺🇸Austin, Texas, United States