A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF SEMAGLUTIDE 0.25 MG AND DULAGLUTIDE 0.75 MG ADMINISTERED SC

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2019
INTERVENTION: Trade Name: Ozempic Pharmaceutical Form: Solution for injection INN or Proposed INN: SEMAGLUTIDE CAS Number: 910463‐68‐2 Other descriptive name: SEMAGLUTIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.34‐ Trade Name: Trulicity Pharmaceutical Form: Solution for injection INN or Proposed INN: DULAGLUTIDE Other descriptive name: DULAGLUTIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.5‐ CONDITION: Healthy volunteers (Diabetes Mellitus, Type 2) (Overweight) (Obesity) ; MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders ; MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 ‐ Metabolism and nutrition disorders ; MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: The primary objective is to compare, in healthy subjects with overweight or obesity, the injection site pain experience of a single dose of semaglutide 0.25 mg sc using the semaglutide product compared to a single dose of dulaglutide 0.75 mg sc using the dulaglutide product. Primary end point(s): Intensity of injection site pain Secondary Objective: N/A Timepoint(s) of evaluation of this end point: 1 minute after each injection (Day 1) SECONDARY OUTCOME: Secondary end point(s): N/A Timepoint(s) of evaluation of this end point: N/A INCLUSION CRITERIA: ‐ Male or female, aged 18‐75 years (both inclusive) at the time of signing informed consent. ‐ Body mass index equal to or above 25.0 kg/m^2. ‐ Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Epistemonikos ID: 78dc7f28abee4c47fe86ac4dcfd29d2d6ce56a9b
First added on: Aug 24, 2024