Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

NCT04189848 | Completed Phase 4 Results

• 3 other identifiers: NN9535-46482019-83003844-57U1111-1241-0348
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same 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; Overweight; 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 millimeters (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 horizontal line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.

  1 minute after each injection (Day 1)

Study Arms (2)

Semaglutide followed by dulaglutide

EXPERIMENTAL

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

Drug: Semaglutide; Drug: Dulaglutide

Dulaglutide followed by semaglutide

EXPERIMENTAL

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

Drug: Semaglutide; Drug: Dulaglutide

Interventions

Semaglutide DRUG

Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.

Dulaglutide followed by semaglutide; Semaglutide followed by dulaglutide

Dulaglutide DRUG

Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.

Dulaglutide followed by semaglutide; Semaglutide followed by dulaglutide

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 trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• 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.

You may not qualify if:

• Known or suspected hypersensitivity to trial product(s) or related products.
• Previous participation in trial INS-4603, INS-4582 or NN9535-4648. Participation is defined as having received investigational product.
• Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 or is of childbearing potential and not using highly effective contraceptive methods.
• Participation in a drug study within 60 days prior to drug administration in the current trial OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current trial.
• Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
• Glycosylated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
• Supine blood pressure at screening (after resting for 5 minutes or longer) outside the range of 90-160 mmHg for systolic or 45-89 mmHg for diastolic.
• Supine pulse rate (as part of vital signs) outside the range of 40-100 beats/min after resting for 5 minutes or longer at screening.
• Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives and occasional use of paracetamol (not allowed within 24 hours prior to drug administration), within 14 days prior to Day 1.
• Diagnostic test results positive for HIV-1 or HIV-2 infection.
• Diagnostic test results positive for active 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 trial 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 centre.
• 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, Berg B, van Marle S, Sparre T. Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects. Diabetes Obes Metab. 2021 Jun;23(6):1415-1419. doi: 10.1111/dom.14349. Epub 2021 Mar 18.

  PMID: 33591618 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Interventions

semaglutide; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 3, 2019
• Primary Completion: January 29, 2020
• Study Completion: February 27, 2020
• Last Updated: November 7, 2022
• Results First Posted: February 17, 2021

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)