Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01572753
First received: April 4, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Healthy
Drug: semaglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral Semaglutide in Healthy Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing [ Time Frame: 0-24hrs after the 10th dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax; The maximum plasma semaglutide concentration [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]
  • tmax; Time to maximum plasma semaglutide concentration [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]
  • t1/2; the terminal half-life of semaglutide [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post-dose fasting 120 mins/50 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 60 mins/50 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 30 mins/50 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 15 mins/50 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 120 mins/120 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 60 mins/120 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 30 mins/120 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Experimental: Post-dose fasting 15 mins/120 ml water Drug: semaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.

  Eligibility

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

Inclusion Criteria:

  • Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
  • Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
  • Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
  • History of acute idiopathic or chronic pancreatitis
  • Calcitonin value equal to or above 50 ng/L
  • Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10^9/L (normal range is 3.91 to 8.77x10^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
  • Any clinically significant abnormal ECG, as judged by the investigator
  • Subjects who are smokers
  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: NCT01572753

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tine Aggerholm Bækdal Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01572753     History of Changes
Other Study ID Numbers: NN9924-3794, 2010-019653-17, U1111-1120-6776
Study First Received: April 4, 2012
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014