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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: semaglutide

• Registration Number: NCT01572753
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Study Start: 2012-04-12
• Primary Completion: 2012-09-08
• Study Completion: 2012-09-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-dose fasting 60 mins/50 ml water	semaglutide	-
Post-dose fasting 120 mins/50 ml water	semaglutide	-
Post-dose fasting 30 mins/50 ml water	semaglutide	-
Post-dose fasting 15 mins/50 ml water	semaglutide	-
Post-dose fasting 60 mins/120 ml water	semaglutide	-
Post-dose fasting 120 mins/120 ml water	semaglutide	-
Post-dose fasting 30 mins/120 ml water	semaglutide	-
Post-dose fasting 15 mins/120 ml water	semaglutide	-

Primary Outcome Measures

Name	Time	Method
AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing	0-24hrs after the 10th dosing

Secondary Outcome Measures

Name	Time	Method
t1/2; the terminal half-life of semaglutide	Post-dose at day 10
Cmax; The maximum plasma semaglutide concentration	Post-dose at day 10
tmax; Time to maximum plasma semaglutide concentration	Post-dose at day 10

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany