A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

Study Overview
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Brief Summary
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This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.

Official Title
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A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Semaglutide, 0.5 mg/mL
* Drug: Semaglutide, 1.0 mg/mL
* Drug: Semaglutide, 1.34 mg/mL
* Drug: Semaglutide, 2.0 mg/mL
* Device: DV3372, 0.5 mg/mL
* Device: DV3372, 1.0 mg/mL
* Device: PDS290
* Device: NovoPen®4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive). 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. Exclusion Criteria: Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening. Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening. Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Semaglutide 0.25 mg<br>Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. | Drug: Semaglutide, 0.5 mg/mL<br>* A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.<br>Drug: Semaglutide, 1.34 mg/mL<br>* A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.<br>Device: DV3372, 0.5 mg/mL<br>* DV3372 device will be used for administration of semaglutide 0.5 mg/mL.<br>Device: PDS290<br>* PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.<br>|
| Experimental: Cohort 2: Semaglutide 0.5 mg<br>Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. | Drug: Semaglutide, 1.0 mg/mL<br>* A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.<br>Drug: Semaglutide, 1.34 mg/mL<br>* A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.<br>Device: DV3372, 1.0 mg/mL<br>* DV3372 device will be used for administration of semaglutide 1.0 mg/mL.<br>Device: PDS290<br>* PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.<br>|
| Experimental: Cohort 3: Semaglutide 0.5 mg<br>Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks. | Drug: Semaglutide, 1.34 mg/mL<br>* A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.<br>Drug: Semaglutide, 2.0 mg/mL<br>* A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.<br>Device: PDS290<br>* PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.<br>Device: NovoPen®4<br>* NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration | Measured in nmol·h/L. | 0-840 hours (5 weeks) | 
| Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration | Measured in nmol/L. | 0-840 hours (5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration | Measured in nmol·h/L. | 0-840 hours (5 weeks) | 
| tmax,sema,SD, time to Cmax,sema,SD of semaglutide | Measured in hours. | 0-840 hours (5 weeks) | 
| t½,sema,SD, terminal elimination half-life of semaglutide | Measured in hours. | 0-840 hours (5 weeks) | 
| Cl/F,sema,SD, total apparent clearance of semaglutide | Measured in L/h. | 0-840 hours (5 weeks) | 
| Vz/F,sema,SD, apparent volume of distribution of semaglutide | Measured in L. | 0-840 hours (5 weeks) | 
| Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL | Count of technical complaints. | Week 0-5 in both treatment period 1 and 2 | 
| Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL | Count of technical complaints. | Week 0-5 in both treatment period 1 and 2 |