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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:
ClinicalTrials.gov Identifier:
NCT01766245
First Posted: January 11, 2013
Last Update Posted: June 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
  • Cmax, the maximum plasma semaglutide concentration [ Time Frame: 20-40 hours after a single dose s.c. semaglutide administration ]

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 ]
  • tmax, time to Cmax of semaglutide [ Time Frame: 20-40 hours ]
  • t½, terminal elimination half-life of semaglutide [ Time Frame: 140-200 hours ]
  • Incidence of adverse events (AEs) [ Time Frame: From first dosing to follow-up (5-7 weeks after the second dosing) ]
  • Hypoglycaemic episodes [ Time Frame: From first dosing to follow-up (5-7 weeks after the second dosing) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01766245     History of Changes
Other Study ID Numbers: NN9535-4010
2012-002212-20 ( EudraCT Number )
U1111-1130-3931 ( Other Identifier: WHO )
First Submitted: December 19, 2012
First Posted: January 11, 2013
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Novo Nordisk A/S:
mm