Type 2 Diabetes Mellitus
Conditions
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).
Interventions
DRUGSAR425899
Pharmaceutical form: Solution Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Absolute frequency of GI AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed