NCT01686945

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Sep 2012

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 19, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2013

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

September 13, 2012

Last Update Submit

January 2, 2019

Conditions

DiabetesDiabetes Mellitus, Type 2Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of treatment emergent adverse events (TEAEs) recorded

    From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)

Secondary Outcomes (6)

  • Area under the plasma concentration curve over the dosing interval (0-24 hours)

    After the last 3 daily doses for semaglutide and carrier

  • Change from baseline in fasting plasma glucose (FPG)

    Week 0, week 10 (Day 69)

  • Change from baseline in C-peptide

    Week 0, week 10 (Day 69)

  • Change from baseline in insulin

    Week 0, week 10 (Day 69)

  • Change from baseline in glucagon

    Week 0, week 10 (Day 69)

  • +1 more secondary outcomes

Study Arms (4)

Healthy - 20 mg

EXPERIMENTAL
Drug: semaglutideDrug: placebo

Healthy - 40 mg

EXPERIMENTAL
Drug: semaglutideDrug: placebo

Healthy - 60 mg

EXPERIMENTAL
Drug: semaglutideDrug: placebo

T2D - 20/40/60 mg

EXPERIMENTAL
Drug: semaglutideDrug: placebo

Interventions

semaglutideDRUG

Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.

Healthy - 20 mg
placeboDRUG

Placebo semaglutide. For oral administration.

Healthy - 20 mgHealthy - 40 mgHealthy - 60 mgT2D - 20/40/60 mg

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
  • Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m\^2. b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m\^2
  • Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with T2D: between 6.5 and 9.0% (both inclusive)

You may not qualify if:

  • History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
  • Blood pressure in supine position at the screening examination above: a) 140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D
  • Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
  • Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
  • Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60. The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race
  • Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
  • Clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1) at the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (2)

  • Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492.

    PMID: 30566096RESULT

  • Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.

    PMID: 30565096DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

September 13, 2012

First Posted

September 18, 2012

Study Start

September 19, 2012

Primary Completion

April 8, 2013

Study Completion

April 8, 2013

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

DE(1)