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

NCT ID: NCT01324505

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One-sequence cross-over arm

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.

Microgyn®

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

placebo

Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

References

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)

Reference Type: RESULT

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1119-2214

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022435-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9535-3819

Identifier Type: -

Identifier Source: org_study_id