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CompletedNCT02212067Updated Mar 7, 2018

A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

A Phase 1 interventional study of semaglutide and placebo in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 87 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Semaglutide

    Total of 12 visits

    Drug: semaglutide

  • Placebo comparator
    Placebo

    Total of 12 visits

    Drug: placebo

  • No intervention
    Healthy subjects

    Total of 2 visits

Interventions

  • Drugsemaglutide

    Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

  • Drugplacebo

    Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge

    Time frame: Day -1, day 86

  3. 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

  4. 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

  5. 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

  6. Slope of the ISR vs. glucose curve (dose-response relationship)

    Time frame: Day -1, day 87

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Neuss, 41460, Germany
08

References and documents

Publications

  • Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19. PubMed 28526920 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02212067
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Aug 8, 2014
Start date
Aug 11, 2014
Primary completion
May 11, 2015
Completion
May 11, 2015
Last update
Mar 7, 2018

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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