Clinical trial NCT01324505: Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the ethinylestradiol concentration-time curve
timeFrame: in the 24 hour dosing interval
measure: Area under the levonorgestrel concentration-time curve
timeFrame: in the 24 hour dosing interval
Secondary outcomes:
measure: Maximum oral contraceptive concentration
timeFrame: in the 24 hour dosing interval
measure: Area under the semaglutide concentration-time curve
timeFrame: in the 24 hour dosing interval
measure: Maximum semaglutide concentration
timeFrame: within the weekly dosing interval
measure: Percentage of subjects experiencing adverse events
timeFrame: from week 1 to end of trial at maximum 23 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kapitza C, Nosek L, Jensen L, Hartvig H, Jensen CB, Flint A. Semaglutide, a once-weekly human GLP-1 analogue, does not reduce the bioavailability of oral contraceptives in patients with type 2 diabetes. Diabetes 2014; 63 (suppl 1): A595-A631 (2383-PO)