PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesPhase 1NCT05760677
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
A Phase 1 study testing pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone and the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and T2D, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong… Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, T2D
- What is being tested?
- pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone and the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2024
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes mellitus Clinical diagnosis of Polycystic ovarian syndrome Must be able to swallow tablets
Who cannot join
- Mental diseases, autoimmune diseases, hematological diseases, malignant tumors, other ovarian diseases (such as ovarian cysts), sexually transmitted diseases Infertility caused by gynecological diseases such as uterine cat's eye disease and other reasons Abnormal function of important organs Congenital adrenocorticosis, hypothyroidism, Cushing's syndrome and other endocrine diseases Patients who have recently prepared or become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes
Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes
Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
Type of study: randomized controlled, prospective, intervention study.
Read the detailed description
From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
- Being tested
- pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazoneDrug
the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ ChiglitazarDrug
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone group | Active comparator | All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ pioglitazone (15mg qd po) Receives: Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone; Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar |
| Chiglitazar group | Experimental | All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD) Receives: Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone; Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma glucose
Assessment the change level of plasma glucose. The unit is mmol/L.
Measured: 12 weeks
The recovery of menstrual cycle
Assessment the recovery of menstrual cycle. The unit is day.
Measured: 12 weeks
Secondary outcomes (1)
The changes in body weight
Assessment the changes of body weight. The unit is kilogram.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760677
- Sponsor's protocol ID
- Chiglitazar sodium
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05760677
- Acronym / sponsor ID
- Chiglitazar sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Mar 2023 (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.
Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes
Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
Type of study: randomized controlled, prospective, intervention study.
Detailed description
From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone group | Active comparator | Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ ChiglitazarAll participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ pioglitazone (15mg qd po) |
| Chiglitazar group | Experimental | Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ ChiglitazarAll participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD) |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Type 2 diabetes mellitus Clinical diagnosis of Polycystic ovarian syndrome Must be able to swallow tablets
Key exclusion criteria (1 listed)
- Mental diseases, autoimmune diseases, hematological diseases, malignant tumors, other ovarian diseases (such as ovarian cysts), sexually transmitted diseases Infertility caused by gynecological diseases such as uterine cat's eye disease and other reasons Abnormal function of important organs Congenital adrenocorticosis, hypothyroidism, Cushing's syndrome and other endocrine diseases Patients who have recently prepared or become pregnant
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 |
|---|---|---|
| pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazonethe pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone | Drug | Chiglitazar group, Pioglitazone group |
| the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazarthe Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) | Drug | Chiglitazar group, Pioglitazone group |
Primary outcome
Change of plasma glucose
Time frame: 12 weeks
Assessment the change level of plasma glucose. The unit is mmol/L.
The recovery of menstrual cycle
Time frame: 12 weeks
Assessment the recovery of menstrual cycle. The unit is day.
1 secondary outcome
The changes in body weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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 1 study testing pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone and the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and T2D, run by Affiliated Hospital of Nantong University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 China. 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?
Results are not available in the source record.
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 of plasma glucose (time frame: 12 weeks). 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?
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 1 Aug 2023.