A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity

NCT04007107 | Completed Phase 2 Results

• 3 other identifiers: INS-45822019-002284-10U1111-1233-9590
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy men and women compares the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (sc, under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

Conditions

Healthy Volunteers Diabetes Mellitus, Type 2; Healthy Volunteers Overweight; Healthy Volunteers Obesity

Outcome Measures

Primary Outcomes (1)

• Intensity of Injection Site Pain

  The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimetres (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.

  After 1 minute of each injection (Day 1)

Study Arms (2)

DV3396 followed by PDS290

EXPERIMENTAL

The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach

Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

PDS290 followed by DV3396

EXPERIMENTAL

The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach

Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

Interventions

Semaglutide (administered by DV3396 pen) DRUG

Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day

DV3396 followed by PDS290; PDS290 followed by DV3396

Semaglutide (administered by PDS290 pen) DRUG

Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day

DV3396 followed by PDS290; PDS290 followed by DV3396

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent.
• BMI 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.

You may not qualify if:

• Known or suspected hypersensitivity to the study product or related products.
• Previous participation in this study. Participation is defined as having received investigational product.
• Woman who is pregnant or breast-feeding or intends to become pregnant within 4 weeks after administration of the study drug, or is of childbearing potential and not using highly effective contraceptive methods with her fertile male sexual partner
• Participation in a drug study within 60 days prior to drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study.
• Any disorder that in the Investigator's opinion might jeopardize subject's safety, evaluation of results, or compliance with the protocol.
• Glycosylated haemoglobin (HbA1c) equal to or above 6.5% at screening.
• Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90 to 160 mmHg for systolic or 45 to 89 mmHg for diastolic.
• Supine pulse rate (as part of vital signs) (after resting for at least 5 minutes) outside the range of 40 to 100 beats per minute.
• Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives, and occasional use of paracetamol (paracetamol not allowed within 24 hours prior to drug administration), within 14 days prior to drug administration.
• Diagnostic test results positive for human immunodeficiency virus (HIV)-1 or HIV-2 infection.
• Diagnostic test results positive for hepatitis B or hepatitis C infection.
• Mental incapacity, language barriers, or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator.
• Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
• Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center.
• Use of tobacco and nicotine products, defined as any of the below:

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• Snitker S, Andersen A, Lindskov PS, van Marle S, Sode BF, Sparre T. Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector. Diabetes Obes Metab. 2022 Aug;24(8):1643-1646. doi: 10.1111/dom.14718. Epub 2022 May 20. No abstract available.

  PMID: 35434913 DERIVED

MeSH Terms

Interventions

semaglutide

Results Point of Contact

• Title: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: June 27, 2019
• Primary Completion: July 28, 2019
• Study Completion: September 4, 2019
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)