DiabetesPhase 1NCT01324505
Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes
A Phase 1 study testing semaglutide and Microgyn® in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- semaglutide and Microgyn®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- semaglutide, placebo, Microgyn®
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
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
placeboDrug
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
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.
| Study group | Role | What they receive |
|---|---|---|
| One-sequence cross-over arm | Experimental | Not described Receives: Drug: semaglutide; Drug: placebo; Drug: Microgyn® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ethinylestradiol concentration-time curve
Measured: in the 24 hour dosing interval
Area under the levonorgestrel concentration-time curve
Measured: in the 24 hour dosing interval
Secondary outcomes (4)
Maximum oral contraceptive concentration
Measured: in the 24 hour dosing interval
Area under the semaglutide concentration-time curve
Measured: in the 24 hour dosing interval
Maximum semaglutide concentration
Measured: within the weekly dosing interval
Percentage of subjects experiencing adverse events
Measured: from week 1 to end of trial at maximum 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324505
- Sponsor's protocol ID
- NN9535-3819
- Other IDs
- U1111-1119-2214, 2010-022435-11
- Status last verified
- Feb 2017
- First submitted
- 25 Mar 2011
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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)
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01324505
- Acronym / sponsor ID
- NN9535-3819
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-sequence cross-over arm | Experimental | Drug: semaglutide, Drug: placebo, Drug: Microgyn® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideSemaglutide 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 | One-sequence cross-over arm |
| placeboPlacebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit. | Drug | One-sequence cross-over arm |
| 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. | Drug | One-sequence cross-over arm |
Primary outcome
Area under the ethinylestradiol concentration-time curve
Time frame: in the 24 hour dosing interval
Area under the levonorgestrel concentration-time curve
Time frame: in the 24 hour dosing interval
4 secondary outcomes
Maximum oral contraceptive concentration
Time frame: in the 24 hour dosing interval
Area under the semaglutide concentration-time curve
Time frame: in the 24 hour dosing interval
Maximum semaglutide concentration
Time frame: within the weekly dosing interval
Percentage of subjects experiencing adverse events
Time frame: from week 1 to end of trial at maximum 23 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Results publicationKapitza 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)
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing semaglutide and Microgyn® in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ethinylestradiol concentration-time curve (time frame: in the 24 hour dosing interval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.