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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02212067
Date of registration: 07/08/2014
Prospective Registration: Yes
Primary sponsor: Novo Nordisk A/S
Public title: A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
Scientific title: A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
Date of first enrolment: August 11, 2014
Target sample size: 87
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02212067
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 1
Countries of recruitment
Germany
Contacts
Name:     Global Clinical Registry (GCR, 1452)
Address: 
Telephone:
Email:
Affiliation:  Novo Nordisk A/S
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: 18-64 years (both inclusive) at the time of signing the informed consent

- For subjects with type 2 diabetes:

- Male and female subjects diagnosed with type 2 diabetes

- Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be
unchanged in a period of 30 days prior to screening

- Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)

- Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)

- For healthy control group for graded glucose infusion:

- Healthy male and female subjects

- BMI between 24.0-32.0 kg/m^2 (both inclusive)

- HbA1c less than 6.5 %

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of child
bearing potential and not using an adequate contraceptive method. Women of child
bearing potential must use an effective method of birth control for the duration of
the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of
semaglutide. Only highly effective methods of birth control are accepted (i.e. one
that results in less than 1% per year failure rate when used consistently and
correctly such as implants, injectables, combined oral contraceptives, some
intrauterine devices), or sexual abstinence or vasectomised partner

- Any clinically significant disease history, in the opinion of the investigator, or
systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic,
neurologic, renal, genitourinary and endocrine, dermatologic or hematologic

- Use of any prescription or non-prescription medication which could interfere with
trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or
specifically: a) current treatment with systemic (oral or i.v.) corticosteroids,
non-selective betablockers, b) thyroid hormones are not allowed unless the use of
these have been stable during the past 2 month prior to screening

- History of drug/chemical substance abuse within 1 year prior to screening, or a
positive result in the urine drug test

- History of alcohol abuse within 1 year prior to screening, or a positive result in the
alcohol breath test

- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)

- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All
Health Condition(s) or Problem(s) studied
Diabetes Mellitus, Type 2
Diabetes
Intervention(s)
Drug: semaglutide
Drug: placebo
Primary Outcome(s)
Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes [Time Frame: Day -1, day 86]
Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT). [Time Frame: Day -1, day 86]
Secondary Outcome(s)
Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile [Time Frame: Day -1, day 87]
Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge [Time Frame: Day -1, day 86]
Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge [Time Frame: Day -1, day 86]
Slope of the ISR vs. glucose curve (dose-response relationship) [Time Frame: Day -1, day 87]
Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile [Time Frame: Day -1, day 86]
24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals [Time Frame: Day -1, day 85]
Secondary ID(s)
NN9535-3635
2013-002173-22
U1111-1143-1206
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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