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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

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ClinicalTrials.gov Identifier: NCT02773381
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE June 2, 2016
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
Area under the serum glucose concentration-time curve [ Time Frame: At 12 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
Area under the plasma glucose concentration-time curve [ Time Frame: At 12 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • Ad libitum energy intake during a lunch meal (following a standardised breakfast meal) [ Time Frame: At 12 weeks of treatment ]
  • Mean postprandial increase in serum glucose concentration [ Time Frame: At 12 weeks of treatment ]
  • Mean postprandial increase in TG (triglycerides) concentration [ Time Frame: At 12 weeks of treatment ]
  • Area under the paracetamol plasma concentration-time curve [ Time Frame: At 12 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • Ad libitum energy intake during a lunch meal (following a standardised breakfast meal) [ Time Frame: Week 0-12 ]
  • Mean postprandial increase in plasma glucose concentration [ Time Frame: At 12 weeks of treatment ]
  • Mean postprandial increase in TG (triglycerides) concentration [ Time Frame: At 12 weeks of treatment ]
  • Area under the paracetamol plasma concentration-time curve [ Time Frame: At 12 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    Oral administration once-daily.
  • Drug: placebo
    Oral administration once-daily.
Study Arms  ICMJE
  • Experimental: Semaglutide 3 mg, 7 mg, 14 mg
    Intervention: Drug: semaglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
22
Actual Study Completion Date  ICMJE October 19, 2018
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773381
Other Study ID Numbers  ICMJE NN9924-4248
2015-003998-14 ( EudraCT Number )
U1111-1174-1070 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP