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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

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 2, 2016
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide 3 mg, 7 mg, 14 mg Drug: semaglutide
Oral administration once-daily.

Placebo Comparator: Placebo Drug: placebo
Oral administration once-daily.




Primary Outcome Measures :
  1. Area under the serum glucose concentration-time curve [ Time Frame: At 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Ad libitum energy intake during a lunch meal (following a standardised breakfast meal) [ Time Frame: At 12 weeks of treatment ]
  2. Mean postprandial increase in serum glucose concentration [ Time Frame: At 12 weeks of treatment ]
  3. Mean postprandial increase in TG (triglycerides) concentration [ Time Frame: At 12 weeks of treatment ]
  4. Area under the paracetamol plasma concentration-time curve [ Time Frame: At 12 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02773381


Locations
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United Kingdom
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS2 9LH
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:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02773381    
Other Study ID Numbers: NN9924-4248
2015-003998-14 ( EudraCT Number )
U1111-1174-1070 ( Other Identifier: WHO )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases