Diabetes Mellitus, Type 1Phase 2PRIFENNCT05909800
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
A Phase 2 study testing Phenofibrate in people with Diabetes Mellitus, Type 1, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes. The main question it aims to answer is: whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Phenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesPoland
- Study dates
- 29 Sep 2022to Jul 2024
- Phase
- Phase 2
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who meet all of the following criteria are eligible to participate in this study:
- Subject or Legally accepted representative (LAR) able to understand and provide signed informed consent. Assent is also required of adolescents and children.
- LAR of subjects ≤ 17 years sign the "Information Leaflet and ICF for the Parent/Legal Guardian of Minor Subject".
- Adolescents from 10-15 years sign "Children Assent form".
- Adolescents from 16-17 years sign "Adolescent Assent form".
- Age ≥10 and ≤ 17 years.
Show all 16Show fewer
- Diagnosis of type 1 diabetes within 8 weeks before randomization (V0 visit) based on positive autoantibody (minimum 1 among: GADA, IA2A, ZnT4, IAA) and symptoms of type 1 diabetes according to the criteria of the Polish Diabetes Association (1 of the following):
- symptoms of diabetes and blood glucose ≥ 200 mg / dl (≥ 11.1 mmol/l),
- when no symptoms or when diabetes symptoms are present and random glucose <200 mg/dl (<11.1 mmol/l) - then confirmation of the diagnosis is fasting blood glucose in 2 measurements ≥ 126 mg/dl (≥ 7.0 mmol/l); each test must be performed on a different day,
- in the absence of symptoms of hyperglycaemia and random glycaemia ≥ 200 mg/dl (11.1 mmol/l), fasting glucose ≥ 126 mg/dl (7.0 mmol/l) is a confirmation of the diagnosis,
- if once or twice fasting blood glucose is 100-125 mg / dl (5.6-6.9 mmol/l), or if fasting blood glucose is below 100 mg/dl (5.6 mmol/l) ) exists, If there is a reasonable suspicion of impaired glucose tolerance or diabetes mellitus, an oral glucose tolerance test (OGTT) should be performed. At the 120th minute of the OGTT, blood glucose ≥ 200 mg/dl (11.1 mmol/l) confirms the diagnosis of diabetes.
- Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Acceptable birth control methods are the following:
- Intrauterine device in place for at least 3 months.
- Use of condom or diaphragm with spermicide for at least 14 days prior to the Visit 0 visit and through study completion.
- Stable hormonal contraceptive for at least 2 months prior to the Visit 0 and continuing through study completion.
- Females (menstruating) must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Visit 0.
Who cannot join
- Subjects who meet any of the following criteria are not eligible to participate in this study:
- Age under 10 or over 17.
- Lack of consent of at least one the guardian LAR to participate in the study.
- Treatment with any oral or injected anti-diabetic medications other than insulin.
- The Subject or close Subject's family history, past or present of allergic or hypersensitivity reactions to fenofibrate or any of the excipients (including patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption).
- Severe hypersensitivity reaction to any other drug.
Show all 19Show fewer
- Subjects with current or history of clinically significant renal impairment.
- Subjects with current or history of clinically significant hepatic impairment.
- Subjects with or history of significant gastrointestinal disease including celiac disease, gastroparesis, another disorder of intestinal absorption or motility.
- Subject with current or history of gall bladder disease.
- Present or history of chronic or acute pancreatitis, except acute pancreatitis due to severe hypertriglyceridaemia.
- Photosensitivity or phototoxic reactions after the use of fibrates or chemically related substances, e.g. ketoprofen.
- Subjects who tested positive for pregnancy at screening and V0 visit or who are currently breastfeeding.
- Low blood albumin defined as clinically significant by investigator.
- Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including personal and familial history of hereditary muscular disorders. Unexplained persistent elevated creatine phosphokinase levels considered clinically significant by the investigator.
- The presence of circumstances that the Investigator considers problematic when obtaining informed consent or meeting the study guidelines, or that may invalidate the interpretation of test results or expose Subjects to unnecessary risk.
- Inability or unwillingness to comply with study procedures.
- Any medical condition or treatment the Investigator believes may expose the Subject to unnecessary risk during the study.
- Participation in interventional or other drug research studies which could affect the objectives of this study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Clinical department of pediatric diabetology and paediatrics, DSK UCKWUM
Warsaw, Masovian Voivodeship, 02-091
Agnieszka Szypowska, MD, PhD, Professor, +480223179425, agnieszka.szypowska@uckwum.pl
Agnieszka Kowalska, MD, PhD, +480223179425, agnieszka.kowalska@uckwum.pl
- Recruiting
Diabetology Department, Children's Memorial Health Institute
Warsaw, Masovian Voivodeship, 04-730
Marta Wysocka- Mincewicz, MD, PhD, +48 22 815 75 78, oddzial.diabetologia@ipczd.pl
Marta Wysocka- Mincewicz, MD, PhD
About this study
Official title: Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy of Phenofibrate Treatment on the Functions of Beta Cells in Children and Adolescents With Newly Diagnosed of Type 1 Diabetes.
The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes. The main question it aims to answer is: whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion. Participants will be asked to take a phenofibrate or identically appearing placebo (a neutral substance), orally, once daily, for 12 months with no knowledge what is administred to them. They will be invited for follow-up visits including blood tests every 3 months. Researchers will be monitoring the two groups for the safety of the phenofibrate, and at the trial end they compare the residual insulin secretion results in two groups.
Read the detailed description
Rationale:
Preservation of residual pancreatic beta cell function in children with newly diagnosed T1D gives a chance for better diabetes control, reduction of chronic diabetes complications, and possibly temporary insulin withdrawal. Indication of a cheap drug for secondary prevention of T1D.
Setting:
Recruitment will be through the paediatric diabetes clinics at two participating centres in Warsaw, Poland (Department of Paediatrics, the Medical University of Warsaw and Department of Endocrinology and Diabetology, Children's Memorial Health Institute).
The initiation of study treatment may be performed no later than 28 days after screening visit, and no later than in 8 weeks from diabetes diagnosis.
PICO:
Adolescent participants meeting inclusion criteria, newly diagnosed with type 1 diabetes will be randomly assigned to two groups, receiving either fenofibrate at a dose of 160 mg or placebo, and regularly assesed, every 3 months for the next year. Assuming increase by 50% of AUC of C-peptide in the test group compared to placebo, 88 subjects are needed to achieve power of 85%. If about 13% drop-out is assumed the total group size is 102 patients. Given randomization ratio 1:1, there is 51 patients in each group.
Main study procedures:
- Demographic and medical history.
- Physical examination and vital signs: heart rate and blood pressure, respiration rate, body temperature.
- Blood collection for laboratory analysis (hematology: morphology with automatic blood smear, biochemistry: ALT, AST, total bilirubin, albumin, amylase, lipase, total cholesterol, HDL, LDL, triglycerides, GGTP, HbA1c, TSH, FT4, Anti-Tg, Anti-TPO, CK, creatinine, urea, vitamin D, homocysteine, Anti-tTG IgA, IgA.
- Urine pregnancy test (in girls with childbearing potential).
- C-peptide and Glucose in MMTT stimulation assay.
- Anti-insulin IAA antibodies, Antibodies to glutamic acid decarboxylase (GADA), Antibodies to tyrosine phosphatase (IA2A), Antibodies to the zinc transporter 8 (ZnT8).
- IL1, IL2, IL10.
- TNF alpha, IFN gamma.
- Genetic study - WES genome sequencing, HLA DR3, DR4, DO8, DQ7.
- FGM Libre Free Style Glucose Monitoring System.
- Abdominal ultrasound.
- Ultrasound of the thyroid gland.
- Safety monitoring and AE collection.
- IMP administration. Compliance will be assessed by collecting empty packages as well as by direct interview and participants receiving <75% of the recommended doses will be considered as non-compliant.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Phenofibrate, Placebo
- Keywords
- Diabetes Mellitus, sulfatide, phenofibrate, children, adolescents, randomized controlled trial, fenofibrate
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenofibrateDrug
Also called Fenofibrate, Fenofibratum, SUB07576MIG, CAS no. 49562-28-9
Administred orally, once daily, for 12 months.
PlaceboDrug
Also called inactive drug, inactive medicine, inactive substance.
Administred orally, once daily, for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Phenofibrate | Experimental | Phenofibrate in capsules received orally, daily, for 12 months. Receives: Drug: Phenofibrate |
| Placebo | Placebo comparator | Capsules containing Microcrystalline cellulose 102,594 mg (99%) and Magnesium stearate 6 mg (1%) identical to those of the active product received orally, daily, for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in AUC in C-peptide stimulation test
Assessment of pancreatic beta cell function by comparing the area under the curve (AUC) in the C-peptide stimulation test: Change in the mean insulin secretion measured on the basis of the C-peptide area under the curve in the stimulation test
Measured: 12 months
Secondary outcomes (11)
Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration
Fasting C-peptide concentration in the stimulation test
Measured: 0, 6, 12 months
Differences in parameters of diabetes control
HbA1c
Measured: 0,3,6,9,12 months
Daily insulin requirement
Daily insulin requirement/kg of body mass
Measured: 0,3,6,9,12 months
Interleukins
IL1, IL2, IL10, TNF alpha, IFN gamma
Measured: 0,6,12 months
Adverse Events occurence
Safety will be evaluated through assessment of AEs, vital signs, physical examinations, USG findings, and laboratory evaluations. Any clinically significant laboratory occurring after study drug initiation must be reported by the investigator as an AE and/or SAE, as appropriate, and must be followed by additional laboratory evaluations until they return to normal range, stabilize, or until the change is no longer clinically relevant. All safety analyses will be conducted using the Safety Analysis Set. Adverse event data will be presented and tabulated according to MedDRA classification.
Measured: 0,3,6,9,12 months
Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration
Maximum C-peptide concentration
Measured: 0,6,12 months
Diabetes control and glucose fluctuations
Mean blood glucose with standard deviation
Measured: 0,3,6,9,12 months
Differences in glucose fluctuations
Glucose variability index (CV%)
Measured: 0,3,6,9,12 months
Parameter of glucose fluctuations
Time in range 70-180mg/dl
Measured: 0,3,6,9,12 months
Difference in autoantibodies
Difference in anti-insulin IAA antibodies, antibodies against glutamic acid decarboxylase (GADA), antibodies to tyrosine phosphatase (IA2A), anti-zinc transporter antibodies 8 determination.
Measured: 0,6,12 month
Genetical analysis
WES Whole Exome Sequencing and HLA
Measured: 1 per study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start29 Sep 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two groups, receiving either phenofibrate at a dose of 160 mg or placebo, orally, once daily, for 12 months. All study participants will be followed up for up to 12 months after the start of the intervention. Study visits at month 3, 6, 9 and 12 will be coordinated with diabetes outpatient clinic visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Memorial Health Institute, Poland
- Responsible party
- Principal investigator, AGNIESZKA SZYPOWSKA, Medical University of Warsaw
- Investigators
- Agnieszka Szypowska, MD, PhD,Prof, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909800
- Sponsor's protocol ID
- PRIFEN-01
- Other IDs
- 2020-003916-28
- Acronym
- PRIFEN
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data relevant to the study will be included in the article or uploaded as supplementary information
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy of Phenofibrate Treatment on the Functions of Beta Cells in Children and Adolescents With Newly Diagnosed of Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT05909800
- Acronym / sponsor ID
- PRIFEN / PRIFEN-01
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, sulfatide, phenofibrate, children, adolescents, randomized controlled trial, fenofibrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Children's Memorial Health Institute, Poland
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Jun 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.
The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes. The main question it aims to answer is: whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion. Participants will be asked to take a phenofibrate or identically appearing placebo (a neutral substance), orally, once daily, for 12 months with no knowledge what is administred to them. They will be invited for follow-up visits including blood tests every 3 months. Researchers will be monitoring the two groups for the safety of the phenofibrate, and at the trial end they compare the residual insulin secretion results in two groups.
Detailed description
Rationale:
Preservation of residual pancreatic beta cell function in children with newly diagnosed T1D gives a chance for better diabetes control, reduction of chronic diabetes complications, and possibly temporary insulin withdrawal. Indication of a cheap drug for secondary prevention of T1D.
Setting:
Recruitment will be through the paediatric diabetes clinics at two participating centres in Warsaw, Poland (Department of Paediatrics, the Medical University of Warsaw and Department of Endocrinology and Diabetology, Children's Memorial Health Institute).
The initiation of study treatment may be performed no later than 28 days after screening visit, and no later than in 8 weeks from diabetes diagnosis.
PICO:
Adolescent participants meeting inclusion criteria, newly diagnosed with type 1 diabetes will be randomly assigned to two groups, receiving either fenofibrate at a dose of 160 mg or placebo, and regularly assesed, every 3 months for the next year. Assuming increase by 50% of AUC of C-peptide in the test group compared to placebo, 88 subjects are needed to achieve power of 85%. If about 13% drop-out is assumed the total group size is 102 patients. Given randomization ratio 1:1, there is 51 patients in each group.
Main study procedures:
- Demographic and medical history.
- Physical examination and vital signs: heart rate and blood pressure, respiration rate, body temperature.
- Blood collection for laboratory analysis (hematology: morphology with automatic blood smear, biochemistry: ALT, AST, total bilirubin, albumin, amylase, lipase, total cholesterol, HDL, LDL, triglycerides, GGTP, HbA1c, TSH, FT4, Anti-Tg, Anti-TPO, CK, creatinine, urea, vitamin D, homocysteine, Anti-tTG IgA, IgA.
- Urine pregnancy test (in girls with childbearing potential).
- C-peptide and Glucose in MMTT stimulation assay.
- Anti-insulin IAA antibodies, Antibodies to glutamic acid decarboxylase (GADA), Antibodies to tyrosine phosphatase (IA2A), Antibodies to the zinc transporter 8 (ZnT8).
- IL1, IL2, IL10.
- TNF alpha, IFN gamma.
- Genetic study - WES genome sequencing, HLA DR3, DR4, DO8, DQ7.
- FGM Libre Free Style Glucose Monitoring System.
- Abdominal ultrasound.
- Ultrasound of the thyroid gland.
- Safety monitoring and AE collection.
- IMP administration. Compliance will be assessed by collecting empty packages as well as by direct interview and participants receiving <75% of the recommended doses will be considered as non-compliant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups, receiving either phenofibrate at a dose of 160 mg or placebo, orally, once daily, for 12 months. All study participants will be followed up for up to 12 months after the start of the intervention. Study visits at month 3, 6, 9 and 12 will be coordinated with diabetes outpatient clinic visits.
| Arm | Type | Receives |
|---|---|---|
| Phenofibrate | Experimental | Drug: PhenofibratePhenofibrate in capsules received orally, daily, for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboCapsules containing Microcrystalline cellulose 102,594 mg (99%) and Magnesium stearate 6 mg (1%) identical to those of the active product received orally, daily, for 12 months. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Subjects who meet all of the following criteria are eligible to participate in this study:
- Subject or Legally accepted representative (LAR) able to understand and provide signed informed consent. Assent is also required of adolescents and children.
- Age ≥10 and ≤ 17 years.
- Diagnosis of type 1 diabetes within 8 weeks before randomization (V0 visit) based on positive autoantibody (minimum 1 among: GADA, IA2A, ZnT4, IAA) and symptoms of type 1 diabetes according to the criteria of the Polish Diabetes Association (1 of the following):
- Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Acceptable birth control methods are the following:
Key exclusion criteria (19 listed)
- Subjects who meet any of the following criteria are not eligible to participate in this study:
- Age under 10 or over 17.
- Lack of consent of at least one the guardian LAR to participate in the study.
- Treatment with any oral or injected anti-diabetic medications other than insulin.
- The Subject or close Subject's family history, past or present of allergic or hypersensitivity reactions to fenofibrate or any of the excipients (including patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption).
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 |
|---|---|---|
| PhenofibrateAlso: Fenofibrate, Fenofibratum, SUB07576MIG, CAS no. 49562-28-9Administred orally, once daily, for 12 months. | Drug | Phenofibrate |
| PlaceboAlso: inactive drug, inactive medicine, inactive substance.Administred orally, once daily, for 12 months. | Drug | Placebo |
Primary outcome
Differences in AUC in C-peptide stimulation test
Time frame: 12 months
Assessment of pancreatic beta cell function by comparing the area under the curve (AUC) in the C-peptide stimulation test: Change in the mean insulin secretion measured on the basis of the C-peptide area under the curve in the stimulation test
11 secondary outcomes
Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration
Time frame: 0, 6, 12 months
Differences in parameters of diabetes control
Time frame: 0,3,6,9,12 months
Daily insulin requirement
Time frame: 0,3,6,9,12 months
Interleukins
Time frame: 0,6,12 months
Adverse Events occurence
Time frame: 0,3,6,9,12 months
Differences in C-peptide concentration in the stimulation test: change in the insulin secretion measured on the basis of the fasting C-peptide concentration
Time frame: 0,6,12 months
Diabetes control and glucose fluctuations
Time frame: 0,3,6,9,12 months
Differences in glucose fluctuations
Time frame: 0,3,6,9,12 months
Parameter of glucose fluctuations
Time frame: 0,3,6,9,12 months
Difference in autoantibodies
Time frame: 0,6,12 month
Genetical analysis
Time frame: 1 per study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Yes. The data relevant to the study will be included in the article or uploaded as supplementary information
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Agnieszka Szypowska, MD, PhD,Prof principal investigator
Medical University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenofibrate in people with Diabetes Mellitus, Type 1, run by Medical University of Warsaw at 2 sites in Poland.
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 16 inclusion and 19 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Agnieszka Szypowska, MD, PhD,Prof (+48223179426, agnieszka.szypowska@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in AUC in C-peptide stimulation test (time frame: 12 months). 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 26 Oct 2023.