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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

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ClinicalTrials.gov Identifier: NCT01866748
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Healthy Drug: semaglutide Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Part A (single dose) Drug: semaglutide
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.

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

Experimental: Part B (multiple dose) Drug: semaglutide
Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.

Drug: placebo
In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).




Primary Outcome Measures :
  1. Part A: Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day -1 to Day 24 ]
  2. Part B: Number of treatment emergent adverse events (TEAEs) [ Time Frame: 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 :
  1. Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve [ Time Frame: From time 0 to 24 hours after a single dose (Day 0) ]
  2. Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve [ Time Frame: Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69) ]
  3. Part B: Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Day 0 (pre-dose), day 70 ]
  4. Part B: Change in body weight from baseline [ Time Frame: Day -1, day 70 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01866748


Locations
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Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01866748    
Other Study ID Numbers: NN9928-4048
2012-003199-38 ( EudraCT Number )
U1111-1132-4190 ( Other Identifier: WHO )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases