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

NCT01324505 | Completed Phase 1

• 3 other identifiers: NN9535-3819U1111-1119-22142010-022435-11
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

One-sequence cross-over arm

EXPERIMENTAL

Drug: semaglutide; Drug: placebo; Drug: Microgyn®

Interventions

semaglutide 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

One-sequence cross-over arm

placebo DRUG

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

One-sequence cross-over arm

Microgyn® 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.

One-sequence cross-over arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• 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)

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

DE (1)