Polycystic Ovary SyndromePhase 4NCT02941445
Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
A Phase 4 study testing sitagliptin and metformin and Metformin in people with Polycystic Ovary Syndrome and Body Weight, run by University Medical Centre Ljubljana.
Trial summary
Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Body Weight
- What is being tested?
- sitagliptin and metformin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Aug 2016
- Phase
- Phase 4
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30kg/m2 or higher
Who cannot join
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of multiple endocrine neoplasia type 2
- significant cardiovascular, kidney or hepatic disease
- the use of statins, within 90 days prior to study entry
About this study
Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.
- Conditions
- Polycystic Ovary Syndrome, Body Weight
- Being tested
- sitagliptin and metformin, Metformin
- Keywords
- DPP4-inhibitors
- Medical subject headings
- Polycystic Ovary Syndrome, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptin and metforminDrug
Also called Janumet
MetforminDrug
Also called Glucophage
| Study group | Role | What they receive |
|---|---|---|
| COMBO (sitagliptin and metformin) | Experimental | metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks Receives: Drug: sitagliptin and metformin |
| MET (metformin) | Experimental | metformin 1000 mg BID Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight.
Measured: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.
Secondary outcomes (1)
Change in body mass indey (BMI).
The BMI was calculated as the body mass divided by the square of the body height (kg/m2)
Measured: Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
- Investigators
- Andrej Janež, MD PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941445
- Sponsor's protocol ID
- SITA after LIRA
- Status last verified
- Oct 2015
- First submitted
- 18 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
- ClinicalTrials.gov ID
- NCT02941445
- Acronym / sponsor ID
- SITA after LIRA
- Conditions
- Polycystic Ovary Syndrome, Body Weight
- Keywords
- DPP4-inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Oct 2016 (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.
Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBO (sitagliptin and metformin) | Experimental | Drug: sitagliptin and metforminmetformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks |
| MET (metformin) | Experimental | Drug: Metforminmetformin 1000 mg BID |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30kg/m2 or higher
Key exclusion criteria (6 listed)
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of multiple endocrine neoplasia type 2
- significant cardiovascular, kidney or hepatic disease
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 |
|---|---|---|
| sitagliptin and metforminAlso: Janumet | Drug | COMBO (sitagliptin and metformin) |
| MetforminAlso: Glucophage | Drug | MET (metformin) |
Primary outcome
Change in body weight.
Time frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.
1 secondary outcome
Change in body mass indey (BMI).
Time frame: Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.
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 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Andrej Janež, MD PhD principal investigator
University Medical Centre Ljubljana
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sitagliptin and metformin and Metformin in people with Polycystic Ovary Syndrome and Body Weight, run by University Medical Centre Ljubljana.
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 6 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in body weight. (time frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2016.