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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01324505
First received: March 25, 2011
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: placebo
Drug: Microgyn®
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the ethinylestradiol concentration-time curve [ Time Frame: in the 24 hour dosing interval ] [ Designated as safety issue: No ]
  • Area under the levonorgestrel concentration-time curve [ Time Frame: in the 24 hour dosing interval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum oral contraceptive concentration [ Time Frame: in the 24 hour dosing interval ] [ Designated as safety issue: No ]
  • Area under the semaglutide concentration-time curve [ Time Frame: in the 24 hour dosing interval ] [ Designated as safety issue: No ]
  • Maximum semaglutide concentration [ Time Frame: within the weekly dosing interval ] [ Designated as safety issue: No ]
  • Percentage of subjects experiencing adverse events [ Time Frame: from week 1 to end of trial at maximum 23 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-sequence cross-over arm Drug: 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
Drug: placebo
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324505

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tine Aggerholm Bækdal Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01324505     History of Changes
Other Study ID Numbers: NN9535-3819, U1111-1119-2214, 2010-022435-11
Study First Received: March 25, 2011
Last Updated: November 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 16, 2014