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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
semaglutide
placebo
Microgyn®
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One-sequence cross-over arm

Arm Description

Outcomes

Primary Outcome Measures

Area under the ethinylestradiol concentration-time curve
Area under the levonorgestrel concentration-time curve

Secondary Outcome Measures

Maximum oral contraceptive concentration
Area under the semaglutide concentration-time curve
Maximum semaglutide concentration
Percentage of subjects experiencing adverse events

Full Information

First Posted
March 25, 2011
Last Updated
February 6, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01324505
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-sequence cross-over arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
Intervention Type
Drug
Intervention Name(s)
Microgyn®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the ethinylestradiol concentration-time curve
Time Frame
in the 24 hour dosing interval
Title
Area under the levonorgestrel concentration-time curve
Time Frame
in the 24 hour dosing interval
Secondary Outcome Measure Information:
Title
Maximum oral contraceptive concentration
Time Frame
in the 24 hour dosing interval
Title
Area under the semaglutide concentration-time curve
Time Frame
in the 24 hour dosing interval
Title
Maximum semaglutide concentration
Time Frame
within the weekly dosing interval
Title
Percentage of subjects experiencing adverse events
Time Frame
from week 1 to end of trial at maximum 23 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
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)
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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