| Trial ID: | L4411 |
| Source ID: | NCT03414736
|
| Associated Drug: |
Sar425899
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: SAR425899
|
| Outcome Measures: |
Primary: Frequency of gastrointestinal (GI) adverse events (AEs), Relative frequency of GI AEs, Main study: Up to week 8; Six-month study extension period: Up to month 8|Frequency of GI AEs, Absolute frequency of GI AEs, Main study: Up to week 8; Six-month study extension period: Up to month 8|Frequency of GI AEs, Severity of GI AEs, Main study: Up to week 8; Six-month study extension period: Up to month 8 | Secondary: 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., 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., 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., Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8|Adverse events (AEs), Number of AEs, Main study: up to week 8; Six-month extension period: up to month 8
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-01-19
|
| Completion Date: |
2018-10-05
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| Results First Posted: |
|
| Last Update Posted: |
2022-04-25
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| Locations: |
Investigational Site Number 8400002, Saint Paul, Minnesota, 55144, United States|Investigational Site Number 8400003, Knoxville, Tennessee, 37920, United States|Investigational Site Number 8400001, Austin, Texas, 78744, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03414736
|
