A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

NCT01766245 | Completed Phase 1

• 3 other identifiers: NN9535-40102012-002212-20U1111-1130-3931
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.

Conditions

Diabetes; Healthy

Keywords

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Outcome Measures

Primary Outcomes (2)

• Area under the plasma semaglutide concentration curve

  0-4 weeks after a single dose s.c. semaglutide administration

• Cmax, the maximum plasma semaglutide concentration

  20-40 hours after a single dose s.c. semaglutide administration

Secondary Outcomes (5)

• The area under the plasma semaglutide concentration curve

  From time 0 to infinity after a single dose s.c. semaglutide administration

• tmax, time to Cmax of semaglutide

  20-40 hours

• t½, terminal elimination half-life of semaglutide

  140-200 hours

• Incidence of adverse events (AEs)

  From first dosing to follow-up (5-7 weeks after the second dosing)

• Hypoglycaemic episodes

  From first dosing to follow-up (5-7 weeks after the second dosing)

Study Arms (2)

Formulation A followed by Formulation B

EXPERIMENTAL

Drug: semaglutide

Formulation B followed by Formulation A

ACTIVE COMPARATOR

Drug: semaglutide

Interventions

semaglutide DRUG

For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.

Formulation A followed by Formulation B; Formulation B followed by Formulation A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• Body mass index (BMI) of 18.5-30 kg/m\^2 (both incl.)

You may not qualify if:

• History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
• Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
• Smoking, drug or alcohol abuse
• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berlin, 13353, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 11, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

DE (1)