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

NCT02773381 | Completed Phase 1

• 3 other identifiers: NN9924-42482015-003998-14U1111-1174-1070
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate 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

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Area under the serum glucose concentration-time curve

  At 12 weeks of treatment

Secondary Outcomes (4)

• Ad libitum energy intake during a lunch meal (following a standardised breakfast meal)

  At 12 weeks of treatment

• Mean postprandial increase in serum glucose concentration

  At 12 weeks of treatment

• Mean postprandial increase in TG (triglycerides) concentration

  At 12 weeks of treatment

• Area under the paracetamol plasma concentration-time curve

  At 12 weeks of treatment

Study Arms (2)

Semaglutide 3 mg, 7 mg, 14 mg

EXPERIMENTAL

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutide DRUG

Oral administration once-daily.

Semaglutide 3 mg, 7 mg, 14 mg

placebo DRUG

Oral administration once-daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
• 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)

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33184979 RESULT

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 16, 2016
• Study Start: June 2, 2016
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

GB (1)