A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes
NCT ID: NCT02773381
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2016-06-02
2018-10-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Semaglutide 3 mg, 7 mg, 14 mg
semaglutide
Oral administration once-daily.
Placebo
placebo
Oral administration once-daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
semaglutide
Oral administration once-daily.
placebo
Oral administration once-daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects diagnosed with type 2 diabetes mellitus for at least 90 days prior to the day of screening.
* Treated with diet and exercise and/or metformin monotherapy. The metformin dose should be unchanged in a period of 30 days prior to screening
* Body mass index (BMI) between 20.0-38 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin) between 6.0-9.0 % (both inclusive)
Exclusion Criteria
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroids Carcinoma
* History of pancreatitis (acute or chronic)
* Presence of clinically significant or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* History or presence of any clinically relevant respiratory, metabolic (including dyslipedimia, however mild dyslipidaemia, defined as screening total cholesterol below or equal to 7.8 mmol/L and screening triglyceride below or equal to 3.42 mmol/L is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
* History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias and conduction disorders
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 mL /min as defined by CKD-EPI using IDMS for serum creatinine measurement on the day of screening
* Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit (UNL) on the day of screening
* Smoker (defined as a subject who is smoking more than 1 cigarette or the equivalent per day). During the in-patient period, the subject must be willing to completely refrain from smoking and use of nicotine substitute products
* Known or suspected alcohol abuse within 1 year from screening (defined as regular intake of more than 21 units weekly for men and 14 units weekly for women - one unit of alcohol equals about 300 mL of beer or lager, one glass (100 mL) of wine, or 25 mL spirits)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Leeds, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gibbons C, Blundell J, Tetens Hoff S, Dahl K, Bauer R, Baekdal T. Effects of oral semaglutide on energy intake, food preference, appetite, control of eating and body weight in subjects with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):581-588. doi: 10.1111/dom.14255. Epub 2020 Nov 27.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003998-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1174-1070
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-4248
Identifier Type: -
Identifier Source: org_study_id