Diabetes Mellitus, Type 1Phase 2NCT07041268
Immunotherapy of the Recent-onset Type 1 Diabetes in Adolescents With Repeated Courses of Rituximab
A Phase 2 study testing rituximab in people with Diabetes Mellitus, Type 1, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
Trial summary
Type 1 diabetes (T1D) is caused by destruction of pancreatic islet beta-cells that produce insulin - the hormone required for glucose uptake by body tissues and organs. Since loss of beta-cells leads to insulin deficiency, blood glucose increases and the symptoms of T1D (thirst, hunger, excessive urination) appear. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesRussia
- Study dates
- 19 Apr 2024to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Is 12 years to 17 years 5 months of age, inclusive, at the time of randomization/initiation of rituximab administration
- Body weight 34-80 kg for males, and 37-80 for females
- Has received a diagnosis of type 1 diabetes mellitus (T1D), ICD-10 codes E10.1 or E10.9, according to the criteria from the Russian Association of Endocrinologists
- The duration of T1D (time from diagnosis to screening) is < 4 months
- Is able to be randomized and initiate rituximab infusions within 4 months (122 days) of the formal T1D diagnosis
- Has a peak stimulated C-peptide of ≥ 200 pmol/L from a MMTT at screening
Show all 9Show fewer
- Is positive for at least one of T1D-related autoantibodies (ICA, GADA, IA-2A, ZnT8A) at screening
- Participant AND his/her legally authorized representative have signed the Informed Consent Form
- Citizenship of the Russian Federation
Who cannot join
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence of current or past infection with Mycobacterium tuberculosis, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening
- Has a history of primary immunodeficiency
- Has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial
- Participant AND his/her legally authorized representative have not signed the Informed Consent Form
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
Yulia V Tikhonovich, M.D., +79163266210, tikhonovich_yu_v@staff.sechenov.ru
Tatiana E Ivannikova, M.D., +79166564245, ivannikova_t_e@staff.sechenov.ru
- Recruiting
Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
Moscow
Elena E Petryaykina, M.D., +74959369251, director@rdkb.ru
Alexei V Timofeev, Ph.D., +79161608994, alvaltim@gmail.com
About this study
Official title: Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is caused by destruction of pancreatic islet beta-cells that produce insulin - the hormone required for glucose uptake by body tissues and organs. Since loss of beta-cells leads to insulin deficiency, blood glucose increases and the symptoms of T1D (thirst, hunger, excessive urination) appear. Inability of patient's tissues and organs to utilize glucose results in rapid weight loss and life-threatening acute T1D complications - ketosis and coma. To ensure glucose consumption by tissues and organs and to prevent acute complications, all patients with T1D need lifelong therapy with insulin. Insulin therapy is also necessary to prevent long-term T1D complications (eye, renal, nerve, and heart problems). By the time T1D is diagnosed, 80-90% of beta-cells have already been destroyed. However, 10-20% viable insulin-producing beta-cells remain in the pancreas over several months and even years after T1D diagnosis. The higher the percentage of the remaining beta-cells, the smaller the risk of long-term complications.
Destruction of beta-cells in T1D has an autoimmune origin. It means that the patient's immune system, which is normally targeted at microbes, viruses, and other non-self substances, mistakenly destroys the beta-cells. The key role in this autoimmune reaction is played by specific cells of the immune system: T- and B-lymphocytes. T-lymphocytes directly damage the beta-cells, while B-lymphocytes support T-lymphocytes activity via antigen presentation mechanisms.
Read more
Rituximab is a drug that specifically eliminates B-lymphocytes from the blood based on the CD20 surface molecule expressed on their surface, as a target. Notably, a subset of currently active T cells, including those potentially associated with pathogenesis of multiple sclerosis, also express CD20 marker on their surface. This makes them a potentially another critically important target of rituximab. In 2009 - 2014, a multicenter study in the U. S. and Canada showed that a single three-week course of rituximab infusions slightly but significantly had improved survival of residual beta-cells and their insulin-producing capacity in patients with recent-onset T1D. However, this beneficial action of rituximab lasted for only one year.
We hypothesized that the repeated courses of rituximab performed over a period of 5 months could produce more profound and durable elimination of pathogenic B- and T- cells, and as a consequence prolonged survival of residual beta-cells and insulin secretion without serious adverse events. Testing this hypothesis is the goal of our study
Read the detailed description
The study is a non-randomized, two-arm, open-label trial in which 1/2 of participants will receive repeated infusions of rituximab and their routine insulin therapy, while the remaining 1/2 will receive their routine insulin therapy only). The group the participant is assigned to is chosen by the participant himself/herself, participant's parent or another legally authorized representative, and by a doctor at the study Clinical Center. In the rituximab group, participants will receive fourteen intravenous infusions of rituximab over a period of 1 year at the study Clinical Center. Over this period, the participants will need to return to the Clinical Center for hospitalization 13 times. At each visit, detailed physical examination and laboratory evaluation will be performed. Participants of the insulin-only group will also need to visit the Clinical Center for physical examination and laboratory evaluation 5 times over a period of 1 year. In both groups, beta-cell survival and insulin-secreting capacity will be assessed by measuring blood C-peptide levels. C-peptide is a small protein secreted by beta-cells together with insulin in equal amounts, thus allowing to assess beta-cell secretory activity in individuals receiving insulin therapy. C-peptide will be measured in the fasting state and at 15, 30, 60, 90, and 120 minutes after oral liquid meal load. This test will be performed at the study start and in the 12th, 19th, 26th, and 52nd week after the start.
In both groups, those participants that continue to secrete insulin will have further follow-up for an additional one year
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- rituximab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Rituximab will be administered intravenously in three courses. The 1st course (loading dose) will include six rituximab infusions on days 1, 3, 5, 8, 14, and 21 of the study. On days 1, 3, and 5 rituximab will be infused at doses of 50, 125, and 200 mg per m2 of the participant's body surface area, respectively. On days 8, 14, and 21 rituximab will be infused at doses of 375 mg/m2, but not more than 500 mg total dose.
The 2nd course (maintenance therapy) will include four rituximab infusions on days 63, 70, 77, and 85 at doses of 375 mg/m2, but not more than 500 mg total dose.
The 3rd course (maintenance therapy) will include four rituximab infusions on days 119, 126, 134, and 140 at doses of 375 mg/m2, but not more than 500 mg total dose
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Rituximab Plus Insulin Therapy Arm | Experimental | In the Rituximab Plus Insulin Therapy Arm, patients will receive repeated courses of rituximab along with their routine insulin therapy Receives: Biological: rituximab |
| Insulin Therapy Only Arm | No intervention | In the Insulin Therapy Only Arm, patients will receive their routine insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mean C-peptide Area Under Curve (AUC) Standardized by Duration of the Mixed Meal Tolerance Test
Calculation of the AUC is based on serum C-peptide measurements performed at 0, 15, 30, 60, 90, and 120 minutes of the MMTT. The AUC is computed using the trapezoidal rule and standardized by the duration of the MMTT, i.e., the mean AUC is expressed algebraically as the AUC/120 min (picomoles/liter/120 min). Commercial nutritional drink is used as a load for MMTT. The drink volume and carbohydrate content are adjusted to participant's weight
Measured: In the Rituximab Plus Insulin Therapy Arm, MMTT will be conducted on study days -1 (the day before the first rituximab infusion), 84, 133, 181, and 365. In the Insulin Therapy Only Arm, MMTT will be conducted on study days 1, 84, 133, 181, and 365
Secondary outcomes (4)
Change in Average Daily Insulin Dose
The average weight-ajusted daily insulin dose will be calculated based on data recorded by participants in their electronic diary (eDiary). Will be assessed in both arms
Measured: Baseline to Day 365
Change in Glycosylated Hemoglobin
Change in content of glycosylated hemoglobin HbA1c in blood, % and mmol/mol. Will be assessed in both arms
Measured: Baseline to Day 365
Time in Range for Glycemia Control
Time in range (%) for glycemia control will be assessed using participant's continuous glucose monitoring (CGM) or flash glucose monitoring (FGM) device. Time in range is defined as daily average percentage of time a participant's glucose is ≥ 3.9 mmol/L and <10 mmol/L. Will be assessed in both arms
Measured: Baseline to Day 365
Frequency of Clinically Significant Hypoglycemia
Frequency here = (clinically significant hypoglycemic episode)/(participant-year). A clinically significant hypoglycemia is defined as a blood glucose level of <3.0 mmol/L or a hypoglycemia episode with severe cognitive impairment requiring external assistance (seizure, syncope, severe confusion) with or without a confirmatory low blood glucose. Hypoglycemia frequency will be calculated for each participant as (number of episodes)/365 days. The number of hypoglycemic episodes will be extracted from participant's eDiary. Will be assessed in both arms
Measured: Baseline to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start19 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitry M Chudakov, Ph.D., D.Sc., Study chair, Institute of Translational medicine, Pirogov Russian National Research Medical UniversityElena E Petryaykina, M.D., Study director, Russian Children's Clinical Hospital, Pirogov Russian National Research Medical UniversityElena S Demina, M.D., Principal investigator, Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041268
- Sponsor's protocol ID
- 2023-11-14
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pescovitz MD, Greenbaum CJ, Bundy B, Becker DJ, Gitelman SE, Goland R, Gottlieb PA, Marks JB, Moran A, Raskin P, Rodriguez H, Schatz DA, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Anti-CD20 Study Group. B-lymphocyte depletion with rituximab and beta-cell function: two-year results. Diabetes Care. 2014 Feb;37(2):453-9. doi: 10.2337/dc13-0626. Epub 2013 Sep 11.
PubMed 24026563Greenbaum CJ, Mandrup-Poulsen T, McGee PF, Battelino T, Haastert B, Ludvigsson J, Pozzilli P, Lachin JM, Kolb H; Type 1 Diabetes Trial Net Research Group; European C-Peptide Trial Study Group. Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes. Diabetes Care. 2008 Oct;31(10):1966-71. doi: 10.2337/dc07-2451. Epub 2008 Jul 15.
PubMed 18628574
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07041268
- Acronym / sponsor ID
- 2023-11-14
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Jun 2025 (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.
Type 1 diabetes (T1D) is caused by destruction of pancreatic islet beta-cells that produce insulin - the hormone required for glucose uptake by body tissues and organs. Since loss of beta-cells leads to insulin deficiency, blood glucose increases and the symptoms of T1D (thirst, hunger, excessive urination) appear. Inability of patient's tissues and organs to utilize glucose results in rapid weight loss and life-threatening acute T1D complications - ketosis and coma. To ensure glucose consumption by tissues and organs and to prevent acute complications, all patients with T1D need lifelong therapy with insulin. Insulin therapy is also necessary to prevent long-term T1D complications (eye, renal, nerve, and heart problems). By the time T1D is diagnosed, 80-90% of beta-cells have already been destroyed. However, 10-20% viable insulin-producing beta-cells remain in the pancreas over several months and even years after T1D diagnosis. The higher the percentage of the remaining beta-cells, the smaller the risk of long-term complications.
Destruction of beta-cells in T1D has an autoimmune origin. It means that the patient's immune system, which is normally targeted at microbes, viruses, and other non-self substances, mistakenly destroys the beta-cells. The key role in this autoimmune reaction is played by specific cells of the immune system: T- and B-lymphocytes. T-lymphocytes directly damage the beta-cells, while B-lymphocytes support T-lymphocytes activity via antigen presentation mechanisms.
Rituximab is a drug that specifically eliminates B-lymphocytes from the blood based on the CD20 surface molecule expressed on their surface, as a target. Notably, a subset of currently active T cells, including those potentially associated with pathogenesis of multiple sclerosis, also express CD20 marker on their surface. This makes them a potentially another critically important target of rituximab. In 2009 - 2014, a multicenter study in the U. S. and Canada showed that a single three-week course of rituximab infusions slightly but significantly had improved survival of residual beta-cells and their insulin-producing capacity in patients with recent-onset T1D. However, this beneficial action of rituximab lasted for only one year.
We hypothesized that the repeated courses of rituximab performed over a period of 5 months could produce more profound and durable elimination of pathogenic B- and T- cells, and as a consequence prolonged survival of residual beta-cells and insulin secretion without serious adverse events. Testing this hypothesis is the goal of our study
Detailed description
The study is a non-randomized, two-arm, open-label trial in which 1/2 of participants will receive repeated infusions of rituximab and their routine insulin therapy, while the remaining 1/2 will receive their routine insulin therapy only). The group the participant is assigned to is chosen by the participant himself/herself, participant's parent or another legally authorized representative, and by a doctor at the study Clinical Center. In the rituximab group, participants will receive fourteen intravenous infusions of rituximab over a period of 1 year at the study Clinical Center. Over this period, the participants will need to return to the Clinical Center for hospitalization 13 times. At each visit, detailed physical examination and laboratory evaluation will be performed. Participants of the insulin-only group will also need to visit the Clinical Center for physical examination and laboratory evaluation 5 times over a period of 1 year. In both groups, beta-cell survival and insulin-secreting capacity will be assessed by measuring blood C-peptide levels. C-peptide is a small protein secreted by beta-cells together with insulin in equal amounts, thus allowing to assess beta-cell secretory activity in individuals receiving insulin therapy. C-peptide will be measured in the fasting state and at 15, 30, 60, 90, and 120 minutes after oral liquid meal load. This test will be performed at the study start and in the 12th, 19th, 26th, and 52nd week after the start.
In both groups, those participants that continue to secrete insulin will have further follow-up for an additional one year
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Rituximab Plus Insulin Therapy Arm | Experimental | Biological: rituximabIn the Rituximab Plus Insulin Therapy Arm, patients will receive repeated courses of rituximab along with their routine insulin therapy |
| Insulin Therapy Only Arm | No intervention | –In the Insulin Therapy Only Arm, patients will receive their routine insulin therapy |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Is 12 years to 17 years 5 months of age, inclusive, at the time of randomization/initiation of rituximab administration
- Body weight 34-80 kg for males, and 37-80 for females
- Has received a diagnosis of type 1 diabetes mellitus (T1D), ICD-10 codes E10.1 or E10.9, according to the criteria from the Russian Association of Endocrinologists
- The duration of T1D (time from diagnosis to screening) is < 4 months
- Is able to be randomized and initiate rituximab infusions within 4 months (122 days) of the formal T1D diagnosis
Key exclusion criteria (6 listed)
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence of current or past infection with Mycobacterium tuberculosis, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening
- Has a history of primary immunodeficiency
- Has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial
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 |
|---|---|---|
| rituximabRituximab will be administered intravenously in three courses. The 1st course (loading dose) will include six rituximab infusions on days 1, 3, 5, 8, 14, and 21 of the study. On days 1, 3, and 5 rituximab will be infused at doses of 50, 125, and 200 mg per m2 of the participant's body surface area, respectively. On days 8, 14, and 21 rituximab will be infused at doses of 375 mg/m2, but not more than 500 mg total dose. The 2nd course (maintenance therapy) will include four rituximab infusions on days 63, 70, 77, and 85 at doses of 375 mg/m2, but not more than 500 mg total dose. The 3rd course (maintenance therapy) will include four rituximab infusions on days 119, 126, 134, and 140 at doses of 375 mg/m2, but not more than 500 mg total dose | Biological | Intervention Arm: Rituximab Plus Insulin Therapy Arm |
Primary outcome
Change in the Mean C-peptide Area Under Curve (AUC) Standardized by Duration of the Mixed Meal Tolerance Test
Time frame: In the Rituximab Plus Insulin Therapy Arm, MMTT will be conducted on study days -1 (the day before the first rituximab infusion), 84, 133, 181, and 365. In the Insulin Therapy Only Arm, MMTT will be conducted on study days 1, 84, 133, 181, and 365
Calculation of the AUC is based on serum C-peptide measurements performed at 0, 15, 30, 60, 90, and 120 minutes of the MMTT. The AUC is computed using the trapezoidal rule and standardized by the duration of the MMTT, i.e., the mean AUC is expressed algebraically as the AUC/120 min (picomoles/liter/120 min). Commercial nutritional drink is used as a load for MMTT. The drink volume and carbohydrate content are adjusted to participant's weight
4 secondary outcomes
Change in Average Daily Insulin Dose
Time frame: Baseline to Day 365
Change in Glycosylated Hemoglobin
Time frame: Baseline to Day 365
Time in Range for Glycemia Control
Time frame: Baseline to Day 365
Frequency of Clinically Significant Hypoglycemia
Time frame: Baseline to Day 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 24026563Pescovitz MD, Greenbaum CJ, Bundy B, Becker DJ, Gitelman SE, Goland R, Gottlieb PA, Marks JB, Moran A, Raskin P, Rodriguez H, Schatz DA, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Anti-CD20 Study Group. B-lymphocyte depletion with rituximab and beta-cell function: two-year results. Diabetes Care. 2014 Feb;37(2):453-9. doi: 10.2337/dc13-0626. Epub 2013 Sep 11.
- Background: PubMed 18628574Greenbaum CJ, Mandrup-Poulsen T, McGee PF, Battelino T, Haastert B, Ludvigsson J, Pozzilli P, Lachin JM, Kolb H; Type 1 Diabetes Trial Net Research Group; European C-Peptide Trial Study Group. Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes. Diabetes Care. 2008 Oct;31(10):1966-71. doi: 10.2337/dc07-2451. Epub 2008 Jul 15.
- Contains the complete version of the Study Protocol (in Russian)Link provided by the sponsor.
- 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.
Dmitry M Chudakov, Ph.D., D.Sc. study chair
Institute of Translational medicine, Pirogov Russian National Research Medical University
Elena E Petryaykina, M.D. study director
Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
Elena S Demina, M.D. principal investigator
Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
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 rituximab in people with Diabetes Mellitus, Type 1, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
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 9 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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 Russia. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena E Petryaykina, M.D. (+79039756179, director@rdkb.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mean C-peptide Area Under Curve (AUC) Standardized by Duration of the Mixed Meal Tolerance Test (time frame: In the Rituximab Plus Insulin Therapy Arm, MMTT will be conducted on study days -1 (the day before the first rituximab infusion), 84, 133, 181, and 365. In the Insulin Therapy Only Arm, MMTT will be conducted on study days 1, 84, 133, 181, and 365). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041268, which also lists 2 linked publications.
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 8 Jul 2025.