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

March 6, 2018 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide
Total of 12 visits
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
Placebo Comparator: Placebo
Total of 12 visits
Drug: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
No Intervention: Healthy subjects
Total of 2 visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Day -1, day 86

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Day -1, day 85
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
Day -1, day 86
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
Day -1, day 87
Slope of the ISR vs. glucose curve (dose-response relationship)
Time Frame: Day -1, day 87
Day -1, day 87

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2014

Primary Completion (Actual)

May 11, 2015

Study Completion (Actual)

May 11, 2015

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-3635
  • 2013-002173-22 (EudraCT Number)
  • U1111-1143-1206 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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