Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01324505
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 43
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description One-sequence cross-over arm placebo - One-sequence cross-over arm Microgyn® - One-sequence cross-over arm semaglutide -
- Primary Outcome Measures
Name Time Method Area under the levonorgestrel concentration-time curve in the 24 hour dosing interval Area under the ethinylestradiol concentration-time curve in the 24 hour dosing interval
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany