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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02212067 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3635Other id2013-002173-22Other idU1111-1143-1206

Overview

Status
Completed
Phase
Phase 1
Enrollment
87 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
11 Aug 2014
Primary completion
11 May 2015
Completion
11 May 2015
First posted
8 Aug 2014 (estimated)
Last update posted
7 Mar 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

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

    NCT02212067

    11 Aug 2014 to 11 May 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • placeboDrug

Arms3

  • Experimental

    Semaglutide

    Total of 12 visits

  • Placebo comparator

    Placebo

    Total of 12 visits

  • No intervention

    Healthy subjects

    Total of 2 visits

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(6)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

7 results

Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.

Kapitza et al. 2017Diabetologiacited by 97

PMID 28526920PMC5491562DOI 10.1007/s00125-017-4289-0PUB-28526920

CC BY7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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