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

NCT01866748 | Completed Phase 1

• 3 other identifiers: NN9928-40482012-003199-38U1111-1132-4190
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

• 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

Study Arms (2)

Part A (single dose)

EXPERIMENTAL

Drug: semaglutide; Drug: placebo

Part B (multiple dose)

EXPERIMENTAL

Drug: semaglutide; Drug: placebo

Interventions

semaglutide DRUG

A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.

Part A (single dose)

placebo DRUG

In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.

Part A (single dose)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berlin, 14050, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

DE (1)