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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: semaglutide
* Drug: placebo
* Drug: Microgyn®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-sequence cross-over arm<br> | Drug: semaglutide<br>* 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<br>Drug: placebo<br>* Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.<br>Drug: Microgyn®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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