Synopsis Protocol Number 2043
Title
A Randomized, Four-Sequence, Crossover, Multiple-Site, Study to Evaluate the Use Success Rate of Pramlintide Acetate Pen Injectors 60 and 120 (Sun Pharmaceutical Industries Ltd.) Compared to SymlinPen® 60 and 120 (AstraZeneca Pharmaceuticals LP) in the Subjects with Type 1 and Type 2 Diabetes
Objectives The primary objectives of this study are to:
1. Demonstrate that the use success rate is consistent and comparable between the SymlinPen® (AstraZeneca Pharmaceuticals LP) and the Pramlintide Acetate Pen (Sun Pharmaceutical Industries Ltd.)
2. Determine if there are any risks associated with subjects alternating between the SymlinPen® (AstraZeneca Pharmaceuticals LP) and Pramlintide Acetate Pen (Sun Pharmaceutical Industries Ltd.)
Sponsor Sun Pharmaceutical Industries Ltd.
Dosage Regimen Subjects will use a simulation injection pad to self-administer four unaided injections. The simulation injection pad will be placed on the subjects preferred injection site, either the abdomen or thigh.
Route of Administration Simulation Injection Pad Subject
Population 60 males and females, 18 years of age and older with Type 1 or Type 2 Diabetes currently using SymlinPen®.
Study Design Randomized, Four-Sequence, Crossover, Multiple-Site, Simulated-Use, Comparative Use Human Factor Study.
Inclusion Criteria:
1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
2. Male or female, 18 years of age or older.
3. Diagnosis of Type I or Type II Diabetes.
4. Current SymlinPen® (AstraZeneca Pharmaceuticals LP) user. 71942601 ■ Rev. 02 ■ 11 Dec 2020 ■ Sun Pharmaceutical Industries Ltd. ■ Page 7 of 59
Exclusion Criteria
1. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
2. Vision impairment, blindness, or inability to self-administer injections.
3. Subjects who have participated in this study previously.
4. Employee of the Investigator or research center or their immediate family members.
5. Non-current SymlinPen® (AstraZeneca Pharmaceuticals LP) user.
Primary Efficacy Endpoint The primary endpoint will be the success rate (SR) observed for both the Test and Reference products. The use SR for the first Test injection (SRT1) and Reference (SRR) will be calculated as 1 plus the proportions of subjects who successfully complete the dosing procedure. That is, subjects must correctly determine that first-use pens must be primed, successfully priming, setting the dose is needed by rotating dose set knob and continue with the procedure for Test and must correctly set the dose by pulling back on the dose knob after dialing the dose for Reference