Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 d...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.
- Patients who are motivated to lose weight.
- Exclusion criteria:
- Type 1 diabetes mellitus.
- Body mass index \<27 kg/m2.
- Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) \>7.0%.
- Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.
- Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.
- Uncontrolled hypertension.
- Laboratory findings at the time of screening: amylase and/or lipase \>2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase \>1.5 ULN, total bilirubin \>1.5 ULN, serum creatinine levels ≥1.5 mg/dL \[males\]. ≥1.4 mg/dL \[females\], screening calcitonin ≥20 pmol/m, fasting serum triglycerides \>400 mg/dL.
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
- History of weight loss surgery.
- History of pancreatitis or pancreatectomy.
- Pregnant or lactating women.
- Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03414736
Start Date
January 19 2018
End Date
October 5 2018
Last Update
April 25 2022
Active Locations (3)
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1
Investigational Site Number 8400002
Saint Paul, Minnesota, United States, 55144
2
Investigational Site Number 8400003
Knoxville, Tennessee, United States, 37920
3
Investigational Site Number 8400001
Austin, Texas, United States, 78744