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Clinical Trial Details

Trial ID: L2267
Source ID: NCT02411825
Associated Drug: Sar425899
Title: Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: SAR425899|DRUG: placebo|DRUG: metformin
Outcome Measures: Primary: Number of adverse events, 28 to 35 days | Secondary: Changes in vital signs, 28 to 35 days|Changes in physical examination, 28 to 35 days|Changes in ECG, 28 to 35 days|Changes in clinical laboratory parameters (hematology), 28 to 35 days|Changes in clinical laboratory parameters (biochemistry), 28 to 35 days|Changes in body temperature, 28 to 35 days|Change from baseline in biomarkers (FGF21), 28 to 35 days|Change from baseline in biomarkers (lipid biomarker), 28 to 35 days|Change from baseline in biomarkers (incretins), 28 to 35 days|Assessment of pharmacokinetic parameters in blood (AUC), 28 to 35 days|Assessment of pharmacokinetic parameters in blood (Cmax), 28 to 35 days|Assessment of pharmacokinetic parameters in blood (t1/2), 28 to 35 days|Assessment of pharmacokinetic parameters in urine (Ae0-24), 28 to 35 days|Assessment of pharmacokinetic parameters in urine (fe0-24), 28 to 35 days|Change from baseline in Body weight, 28 to 35 days|Change from baseline in Fasting Blood Glucose, 28 to 35 days|Change from baseline in Postprandial Blood Glucose, 28 to 35 days|Change from baseline in postprandial Insulin, 28 to 35 days|Change from baseline in postprandial C-peptide profiles, 28 to 35 days|Change from baseline in HbA1c, 28 to 35 days
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-03
Completion Date: 2016-01
Results First Posted:
Last Update Posted: 2018-06-15
Locations: Investigational Site Number 276001, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT02411825