PCOSPhase 4NCT03122041
Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome
A Phase 4 study testing Sitagliptin and Lifestyle intervention in people with PCOS, run by University Medical Centre Ljubljana.
Trial summary
Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Sitagliptin and Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Nov 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to menopause
- polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
- BMI of 30 kg/m2 or higher
Who cannot join
- significant cardiovascular disease
- significant kidney or hepatic disease
- personal or family history of medullary thyroid carcinoma
- known history of gallbladder disease
- known history of pancreatitis
About this study
Official title: Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS
Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.
- Conditions
- PCOS
- Being tested
- Sitagliptin, Lifestyle intervention
- Keywords
- metformin intolerance, PCOS, Sitagliptin, beta cell function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Lifestyle interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SITA | Experimental | Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks Receives: Drug: Sitagliptin; Behavioral: Lifestyle intervention |
| CON | Experimental | Controls (CON) Lifestyle intervention Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).
Measured: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.
Secondary outcomes (2)
The secondary outcome was change in fasting plasma glucose level (G0)
Measured: Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.
The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).
Measured: Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point 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 posted20 Apr 2017
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Ferjan, MD, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122041
- Sponsor's protocol ID
- Metformin Intolerant PCOS
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS
- ClinicalTrials.gov ID
- NCT03122041
- Acronym / sponsor ID
- Metformin Intolerant PCOS
- Conditions
- PCOS
- Keywords
- metformin intolerance, PCOS, Sitagliptin, beta cell function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SITA | Experimental | Drug: Sitagliptin, Behavioral: Lifestyle interventionSitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks |
| CON | Experimental | Behavioral: Lifestyle interventionControls (CON) Lifestyle intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years old to menopause
- polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
- BMI of 30 kg/m2 or higher
Key exclusion criteria (5 listed)
- significant cardiovascular disease
- significant kidney or hepatic disease
- personal or family history of medullary thyroid carcinoma
- known history of gallbladder disease
- known history of pancreatitis
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 |
|---|---|---|
| SitagliptinAlso: Januvia | Drug | SITA |
| Lifestyle intervention | Behavioural | CON, SITA |
Primary outcome
The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).
Time frame: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.
2 secondary outcomes
The secondary outcome was change in fasting plasma glucose level (G0)
Time frame: Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.
The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).
Time frame: Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point 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 20 Apr 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin and Lifestyle intervention in people with PCOS, 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 5 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 20 Apr 2017. 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?
The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index). (time frame: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point 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 20 Apr 2017.