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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01766245
First received: December 19, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: semaglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the plasma semaglutide concentration curve [ Time Frame: 0-4 weeks after a single dose s.c. semaglutide administration ] [ Designated as safety issue: No ]
  • Cmax, the maximum plasma semaglutide concentration [ Time Frame: 20-40 hours after a single dose s.c. semaglutide administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the plasma semaglutide concentration curve [ Time Frame: From time 0 to infinity after a single dose s.c. semaglutide administration ] [ Designated as safety issue: No ]
  • tmax, time to Cmax of semaglutide [ Time Frame: 20-40 hours ] [ Designated as safety issue: No ]
  • t½, terminal elimination half-life of semaglutide [ Time Frame: 140-200 hours ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: From first dosing to follow-up (5-7 weeks after the second dosing) ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: From first dosing to follow-up (5-7 weeks after the second dosing) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A followed by Formulation B Drug: semaglutide
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.
Active Comparator: Formulation B followed by Formulation A Drug: semaglutide
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766245

Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01766245     History of Changes
Other Study ID Numbers: NN9535-4010, 2012-002212-20, U1111-1130-3931
Study First Received: December 19, 2012
Last Updated: June 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novo Nordisk A/S:
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ClinicalTrials.gov processed this record on August 20, 2014