DiabetesPhase 1NCT01508858
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
A Phase 1 study testing liraglutide and levonorgestrel / ethinylestradiol in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Sweden.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide and levonorgestrel / ethinylestradiol
- 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
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Apr 2007
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal woman
- Body Mass Index (BMI) between 18.0-30.0 kg/m^2 (both inclusive)
- Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments
Who cannot join
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
- Impaired renal function
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- Known or suspected allergy to trial products or related products
- Pregnant or positive pregnancy test at screening or nursing mother
Show all 12Show fewer
- Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
- Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
- History of alcoholism or drug abuse
- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
- Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, placebo, levonorgestrel / ethinylestradiol
- 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.
liraglutideDrug
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
placeboDrug
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
levonorgestrel / ethinylestradiolDrug
One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | Not described Receives: Drug: liraglutide; Drug: placebo; Drug: levonorgestrel / ethinylestradiol |
| Treatment period 2 | Placebo comparator | Not described Receives: Drug: liraglutide; Drug: placebo; Drug: levonorgestrel / ethinylestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ethinylestradiol
AUC of levonorgestrel
Secondary outcomes (5)
AUC (0-t)
Cmax, maximum concentration
tmax, time to reach Cmax
t½, terminal half-life
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionApr 2007
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- NCT01508858
- Sponsor's protocol ID
- NN2211-1330
- Other IDs
- 2006-003904-21
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PubMed 25504028
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide
- ClinicalTrials.gov ID
- NCT01508858
- Acronym / sponsor ID
- NN2211-1330
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Jan 2012 (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 trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: liraglutide, Drug: placebo, Drug: levonorgestrel / ethinylestradiol |
| Treatment period 2 | Placebo comparator | Drug: liraglutide, Drug: placebo, Drug: levonorgestrel / ethinylestradiol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal woman
- Body Mass Index (BMI) between 18.0-30.0 kg/m^2 (both inclusive)
- Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments
Key exclusion criteria (12 listed)
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
- Impaired renal function
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- Known or suspected allergy to trial products or related products
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 |
|---|---|---|
| liraglutideAdministered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order | Drug | Treatment period 1, Treatment period 2 |
| placeboAdministered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order | Drug | Treatment period 1, Treatment period 2 |
| levonorgestrel / ethinylestradiolOne single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period | Drug | Treatment period 1, Treatment period 2 |
Primary outcome
AUC of ethinylestradiol
AUC of levonorgestrel
5 secondary outcomes
AUC (0-t)
Cmax, maximum concentration
tmax, time to reach Cmax
t½, terminal half-life
Adverse events
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 24 Jan 2017.
- Results publication: PubMed 25504028Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
- 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 liraglutide and levonorgestrel / ethinylestradiol in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Sweden.
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 3 inclusion and 12 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 24 Jan 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
AUC of ethinylestradiol. 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 NCT01508858, 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 24 Jan 2017.