Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899. Secondary Objectives: * To assess the change in resting, basal and total daily energy expenditure. * To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation. * To assess the change in body composition and core temperature. * To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c). * To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses. * To assess the safety and tolerability.
Detailed description
Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.
Interventions
DRUGSAR425899
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DRUGPlacebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight to obese male and female subjects. * Body mass index 28 - 40 kg/m2. * 18 to 50 years of age * Fasting plasma glucose ≤125 mg/dL. * Glycated hemoglobine (HbA1c) ≤6.5%. * Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia). * No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker). * Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.
Exclusion criteria
* Elevated liver enzymes, lipase, amylase, or calcitonin at screening. * Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening. * Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy. 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 |
|---|---|---|
| Sleep energy expenditure | Baseline to Day 19 | Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting energy expenditure | Baseline to Day 19 | Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo |
| Basal energy expenditure | Baseline to Day 19 | Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo |
| Respiratory quotient (RQ) | Baseline to Day 19 | Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo |
| Fat mass and fat-free mass | Baseline to Day 20 | Change of fat mass and fat-free mass by dual energy X-ray absorptiometry (DEXA) scan from baseline to Day 20 with SAR425899 or placebo |
| Diet Induced Thermogenesis (DIT) | Baseline to Day 19 | Change of DIT from baseline to Day 19 with SAR425899 or placebo |
| Total daily energy expenditure | Baseline to Day 19 | Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo |
| HbA1c | Baseline to Day 20 | Change of HbA1c from baseline to Day 20 with SAR425899 or placebo |
| Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol) | 20 days | Change of lipid biomarkers over time with SAR425899 or placebo |
| Ketone bodies | 20 days | Change of ketone bodies over time with SAR425899 or placebo |
| Adverse events | Up to 27 days | Number of adverse events in patients under treatment with SAR425899 or placebo |
| Pharmacokinetics | Day 16 | Assessment of SAR425899: time to reach Cmax (tmax) |
| Fasting plasma glucose | 20 days | Change of FPG over time with SAR425899 or placebo |
Countries
United States
Outcome results
None listed