Polycystic Ovary SyndromePhase 4NCT02683226
Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
A Phase 4 study testing Vipdomet and Incresync in people with Polycystic Ovary Syndrome and Insulin Resistance, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- What is being tested?
- Vipdomet and Incresync
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2015to Jul 2015
- 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 (NICHD criteria)
- BMI of 30 kg/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 MEN 2
- significant cardiovascular, kidney or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Being tested
- Vipdomet, Incresync
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VipdometDrug
IncresyncDrug
| Study group | Role | What they receive |
|---|---|---|
| metformin and alogliptin | Experimental | Vipdomet 12.5 mg/1000 mg tablets Receives: Drug: Vipdomet |
| pioglitasone and alogliptin | Experimental | Incresync 12,5 mg/30 mg tablets Receives: Drug: Incresync |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.
Measured: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in beta cell function using adaptation index.
Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.
Measured: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in fasting concentration of glucose.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Measured: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in fasting concentration of insulin.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.
Measured: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Secondary outcomes (1)
Secondary outcome was change in body mass index (BMI).
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Measured: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 2015
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
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683226
- Sponsor's protocol ID
- MTT
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2016
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
- ClinicalTrials.gov ID
- NCT02683226
- Acronym / sponsor ID
- MTT
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Feb 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.
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin and alogliptin | Experimental | Drug: VipdometVipdomet 12.5 mg/1000 mg tablets |
| pioglitasone and alogliptin | Experimental | Drug: IncresyncIncresync 12,5 mg/30 mg tablets |
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 (NICHD criteria)
- BMI of 30 kg/m² or higher
Key exclusion criteria (5 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 MEN 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 |
|---|---|---|
| Vipdomet | Drug | metformin and alogliptin |
| Incresync | Drug | pioglitasone and alogliptin |
Primary outcome
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
Time frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.
Primary outcome was change in beta cell function using adaptation index.
Time frame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.
Primary outcome was change in fasting concentration of glucose.
Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Primary outcome was change in fasting concentration of insulin.
Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.
1 secondary outcome
Secondary outcome was change in body mass index (BMI).
Time frame: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint
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 11 May 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vipdomet and Incresync in people with Polycystic Ovary Syndrome and Insulin Resistance, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 11 May 2016. 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 Slovenia. 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 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 insulin resistance measured with homeostasis model assessment (HOMA IR). (time frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.). The study lists 4 primary outcomes in all. 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 11 May 2016.