Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes

February 6, 2017 updated by: Novo Nordisk A/S

An Open-label, One-sequence Cross-over, Single Centre Trial Investigating the Influence of Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug After Multiple Dose Administration of Semaglutide in Subjects With Type 2 Diabetes

This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent obtained by a physician before any trial-related activities
  • Postmenopausal women: a. With at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) above 40 mIU/mL and oestrogen deficiency (estradiol levels less than 30 pg/mL, or a negative gestagen test) or b. Bilateral oophorectomy (surgical removal of both ovaries)
  • Type 2 diabetes treated with either diet and exercise alone or with metformin (monotherapy) having a glycosylated haemoglobin (HbA1c) of 6.5 -10% (both inclusive)
  • Stable treatment of diabetes, either diet and exercise only or a stable dose level of metformin, for at least 3 months
  • BMI (Body Mass Index) between 18.5 - 35.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products
  • Previous participation in this trial. Participation is defined as being dosed with either drug
  • Treatment with antidiabetic drug other than metformin within the last 3 months
  • Use of hormone replacement therapy within 4 weeks prior to starting dosing with the trial product
  • Presence or history of cancer or any clinically significant diseases or disorders, considered by the physician to have influence on the results of this trial
  • Subjects who are known to have hepatitis
  • Positive human immunodeficiency virus (HIV) antibodies
  • Uncontrolled treated/untreated hypertension (systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg)
  • History of alcoholism or drug abuse during the last 3 months
  • History of chronic or idiopathic acute pancreatitis
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (FMTC)
  • Personal history of non-familial medullary thyroid carcinoma
  • Subjects who are considered at increased risk of thrombosis formation, such as deep vein thrombosis, pulmonary embolism, infarction or apoplexy (as judged by the trial physician) and subjects who are smokers
  • Blood or plasma donation within the last 3 months prior to first dosing
  • Participation in any other trial investigating other products or involving blood sampling within the last 3 months prior to first dosing
  • Inability or unwillingness to perform self-injection (with placebo medium) at trial start

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One-sequence cross-over arm
Drug: semaglutide
Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme
Drug: placebo
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
Drug: Microgyn®
Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the ethinylestradiol concentration-time curve
Time Frame: in the 24 hour dosing interval
in the 24 hour dosing interval
Area under the levonorgestrel concentration-time curve
Time Frame: in the 24 hour dosing interval
in the 24 hour dosing interval

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum oral contraceptive concentration
Time Frame: in the 24 hour dosing interval
in the 24 hour dosing interval
Area under the semaglutide concentration-time curve
Time Frame: in the 24 hour dosing interval
in the 24 hour dosing interval
Maximum semaglutide concentration
Time Frame: within the weekly dosing interval
within the weekly dosing interval
Percentage of subjects experiencing adverse events
Time Frame: from week 1 to end of trial at maximum 23 weeks
from week 1 to end of trial at maximum 23 weeks

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

March 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-3819
  • U1111-1119-2214 (Other Identifier: WHO)
  • 2010-022435-11 (EudraCT Number)

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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