Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

Phase 1

Completed

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

• Registration Number: NCT01866748
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-31
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 170

Inclusion Criteria

• Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
• Body Mass Index (BMI) between 20 and 30 kg/m^2
• Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)

Exclusion Criteria

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
• Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A (single dose)	placebo	-
Part B (multiple dose)	semaglutide	-
Part B (multiple dose)	placebo	-
Part A (single dose)	semaglutide	-

Primary Outcome Measures

Name	Time	Method
Part A: Number of treatment emergent adverse events (TEAEs)	Day -1 to Day 24
Part B: Number of treatment emergent adverse events (TEAEs)	Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)

Secondary Outcome Measures

Name	Time	Method
Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve	Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)
Part B: Change in fasting plasma glucose (FPG) from baseline	Day 0 (pre-dose), day 70
Part B: Change in body weight from baseline	Day -1, day 70
Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve	From time 0 to 24 hours after a single dose (Day 0)