Diabetes Mellitus, Type 1Phase 2AIDITNCT03682640
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
A Phase 2 study testing Azithromycin Monohydrate, Insulin Lispro and Dietician support in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Uppsala University at 1 site in Sweden.
Trial summary
Increasing evidences suggest that infections are important etiological factors for the development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the treatment of children, during the first year after diagnosis of T1D with Azithromycin, combined with repeated episodes of intensified insulin… Read more about this study
- Who is it for?
- Ages 72 to 192 months
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Metabolic Disease
- What is being tested?
- Azithromycin Monohydrate, Insulin Lispro and Dietician support
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2018to 31 Dec 2021
- 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 72 to 192 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically diagnosed Type 1 Diabetes. First injection of insulin maximum ten days prior to inclusion.
- Must be willing and capable of taking the study drugs, perform tests and follow up as described as judged by the investigator.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up.
- Aged 6.00 -15.99 years at inclusion.
- Females of childbearing potential must agree to avoid pregnancy during the study period (by abstinence from heterosexual intercourse, or by hormonal or barrier contraception) and have a negative urine pregnancy test.
Who cannot join
- Other diabetes diagnosis than Type 1 diabetes as judged by the investigator
- Severe ketoacidosis (DKA) with lowest pH <7.1 within 36 hours from diagnosis.
- Treatment with any oral or injected anti-diabetic medications other than insulin
- Significantly abnormal haematology results at screening.
- Participation in other clinical trials with a new chemical entity within the previous 3 months.
- Obesity at diagnosis (Iso-BMI ≥ 30 kg/m2 according to http://www.rikshandboken-bhv.se).
Show all 17Show fewer
- Other autoimmune disease present at inclusion that in the opinion of the investigator would interfere with the study protocol.
- Celiac disease present at diagnosis.
- Treatment with medication known to affect glucohomeostasis, i.e. glucocorticoids (inhaled, nasal or skin topic will be accepted), statins, ACE inhibitors.
- Pregnancy or lactation
- Known gastro-intestinal malabsorption disorders
- Abnormalities in ECG or known cardiac disease
- Known hearing defects
- Known hypersensitivity to penicillin
- Inability or unwillingness to comply with the provisions of this protocol
- Presence of serious disease or condition in patient or family, which in the opinion of the investigator makes the patient non-eligible for the study.
- Known renal or hepatic impairment
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
The Queen Silvia Children's Hospital / Sahlgrenska University Hospital
Gothenburg
Gun Forsander
About this study
Increasing evidences suggest that infections are important etiological factors for the development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the treatment of children, during the first year after diagnosis of T1D with Azithromycin, combined with repeated episodes of intensified insulin treatment to induce maximal beta-cell rest, and dietician support to promote dietary habits that minimize the likelihood of bacterial reflux from the duodenum to the pancreatic duct, will lead to preservation of beta cell function.
This trial will examine whether the AIDIT protocol initiated within one week from diagnosis could preserve insulin production in children with Type 1 Diabetes.
Read the detailed description
The study is a 2-arm, randomized, open, single center, clinical trial. Eligible patients with type 1 diabetes will be randomized to the AIDIT protocol or treatment as usual (TAU).
All patients diagnosed with T1D and included in the study will receive standard of care. In addition, the AIDIT protocol will include 1) treatment with Azithromycin for 52 weeks using a protocol for children with cystic fibrosis, 2) repeated treatments with intensified supervised high dose insulin infusion, and 3) extra advice and support from the study dietician.
- Azithromycin Azithromycin will be administered orally. Azithromycin will be given three times per week for 52 weeks. The dose will be 500 mg for children with body weight ≥ 30 kg and 250 mg if body weight < 30 kg.
- Intensified supervised high dose insulin infusions Participants will, in addition to Azithromycin, also be subjected to intensified anti-diabetic treatment to achieve increased beta-cell rest. This will be achieved by insulin lispro given as a supervised iv infusion for 72 hours within one week of diagnosis and by subcutaneous infusion 6-8 hours during one day in study week 5, 9, 13, 17 (±1 week) and 25, 34, 43 (±2 weeks) after inclusion. The intensified treatments will aim to target a blood glucose level of 4.0 ± 0.5 mmol/l. The efficacy of the intended maximal beta cell rest will be evaluated by measurement of plasma glucose and endogenous C-peptide. If C-peptide remains positive during the supervised infusion of insulin lispro this will be interpreted as that the insulin dose needs to be increased at the next treatment occasion to achieve beta-cell rest.
- Dietician support Participants will receive extra advice and support from the study dietician within the first week after randomization, and after 7 and 17 weeks. Personalized nutritional advice on intake of carbohydrates, fat and protein based on four-day food records will be given to in order to reduce insulin resistance and insulin need in accordance with ISPAD guidelines. By giving nutritional advices on less volume of the meals, especially of the fluid (maximum 300 ml per meal), and by trying to extend the meal time to at least 20 minutes, the reflux into ductus pancreaticus might be reduced.
All patients will be offered an examination of their pancreas with MRI at 0 and 12 months after inclusion. In addition, plasma samples taken at inclusion and after 1.5 and 12 months will be analysed for the presence of cell-free DNA indicating ongoing cell destruction. Cell-specific methylation patterns of this cell-free DNA will be analysed to determine cell-type specific cell death.
The effect of the addition of treatment according to the AIDIT protocol will be evaluated with a Mixed Meal Tolerance Test (MMTT) to explore the effect on preservation of beta-cell function.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases, Juvenile Diabetes
- Being tested
- Azithromycin Monohydrate, Insulin Lispro, Dietician support
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Endocrine System Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin MonohydrateDrug
Also called Azithromycin Sandoz, Azithromax
Azithromycin Monohydrate tablet (Azithromycin Sandoz) or oral suspension (Azithromax).
Insulin LisproDrug
Also called Insulin lispro Sanofi
Solution for intravenous or subcutaneous use
Dietician supportBehavioural
Dietary advice
| Study group | Role | What they receive |
|---|---|---|
| AIDIT protocol | Experimental | Treatment as usual with the addition of:
i) Azithromycin Monohydrate, three times a week (≥ 48 h between doses) during 52 weeks. 500 mg if body weight ≥ 30 kg, 250 mg if body weight < 30 kg.
ii) Extra intensive insulin treatment periods for maximum beta-cell rest with Insulin lispro (Sanofi). This treatment will be given i.v. for one episode of 72 hours in the first week after inclusion and s.c. on seven 6-8 h occasions during the study year. The dose will be individually titrated to reach target blood glucose 4.0±0.5 mmol/L.
ii) Dietician support; Extra advice and support from the study dietician within the first week after randomization and after 1.5 and 4 months. Receives: Drug: Azithromycin Monohydrate; Drug: Insulin Lispro; Behavioral: Dietician support |
| Control | No intervention | Patients will receive treatment as usual (TAU). All patients will receive standard therapeutic treatment consisting of insulin replacement with insulin analogues aiming for normoglycemia from diagnosis. Rapid acting insulin analogue will be administered via insulin pump (continuous subcutaneous infusion) with access to insulin injections in case of malfunction in the pump system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulated C-peptide during an MMTT
Residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide two-hour under the curve profile measured one year after study inclusion.
Measured: 12 months after inclusion
Secondary outcomes (21)
>60% of time in target blood glucose levels
Proportion of subjects with time in target 3.9-7.8 mmol/L ≥ 60% and with a glycaemic variability expressed as standard deviation < 2 mmol/L according to continuous glucose monitoring during two weeks in the 12th month after initiation of the study treatment.
Measured: two weeks in the 12th month after initiation of the study treatment
Time in target blood glucose levels
Time in target (3.9-7.8 mmol/L) during 30 days in the 12th month after initiation of the study treatment.
Measured: 30 days in the 12th month after initiation of the study treatment
Time in range blood glucose levels
Time in range (3.9-10 mmol/L) during 30 days in the 12th month after initiation of the study treatment.
Measured: 30 days in the 12th month after initiation of the study treatment
Insulin dose
Mean daily insulin dosage per kilo bodyweight during 30 days in the 12th month after initiation of the study treatment.
Measured: 30 days in the 12th month after initiation of the study treatment
HbA1c levels
HbA1c at 12 months after study initiation
Measured: 12 months
Hypoglycaemic events
Number of severe hypoglycaemic events (hypoglycaemia level 3) during the study year.
Measured: From study start to 12 months
Time in hypoglycemic range
Time in hypoglycaemic range level 1 and 2 (<3.9 mmol/l and <3.0 mmol/l) respectively in CGM registrations during 30 days in the 12th month after initiation of the study treatment.
Measured: 30 days in the 12th month
IDAA1c
Insulin-dose-adjusted HbA1c (IDAA1c) 12 months after study initiation
Measured: 12 months
Pro-insulin/c-peptide
Pro-insulin/c-peptide ratio in serum 12 months after study initiation
Measured: 12 months
Pancreas inflammation
Inflammation in the pancreas measured by contrast enhanced MRI at 12 months after initiation of the study
Measured: 12 months
QoL
Health related Quality of Life; Varni PedsQL, Generic and Diabetes specific questionnaire, by child and proxy (parents or other caregivers) at study start and 12 months after study initiation.
Measured: 12 months
Gastrointestinal symptoms
Questionnaire on gastrointestinal symptoms: "The gastrointestinal symptom rating scale" (GSRS) at study start and 12 months after study initiation .
Measured: 12 months
Time spent eating
Average time spent eating at meals during four days in the 12th month after initiation of the study treatment.
Measured: 12 months
Intake of saturated fat
Intake of saturated fat (E% and if the child reaches Nordic Nutritional Recommendations, NNR) during four days in the 12th month after initiation of the study treatment.
Measured: four days in the 12th month
Intake of fruit
Intake of fruit and vegetables (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment.
Measured: four days in the 12th month
Intake of macronutrients
Intake of macronutrients (E% and g/day) during four days in the 12th month after initiation of the study treatment.
Measured: four days in the 12th month
Intake of fibre
Intake of fibre (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment.
Measured: four days in the 12th month
Physical activity measured with accelerometer
Physical activity registered with accelerometer during one week in the 6th month after initiation of the study treatment.
Measured: 6 months
Physical activity measured with accelerometer
Physical activity registered with accelerometer during one week in the 12th month after initiation of the study treatment.
Measured: 12 months
Oral microbiome
The oral microbiome at 12 months after study initiation.
Measured: 12 months
Change in stimulated C-peptide
Change in stimulated c-peptide two-hour under the curve profile from 6 weeks to 12 months after initiation of study treatment.
Measured: change from 6 weeks to 12 months after initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study startSep 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 Uppsala 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 2-arm, randomized, open, clinical trial comparing the AIDIT protocol with treatment as usual.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Gun Forsander, MD, PhD, Principal investigator, The Queen Silvia Children's Hospital /Sahlgrenska University Hospital (SU), Sahlgrenska Academy, Dept of Pediatrics, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682640
- Sponsor's protocol ID
- AIDIT
- Acronym
- AIDIT
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03682640
- Acronym / sponsor ID
- AIDIT / AIDIT
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases, Juvenile Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Sep 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Sep 2018 (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.
Increasing evidences suggest that infections are important etiological factors for the development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the treatment of children, during the first year after diagnosis of T1D with Azithromycin, combined with repeated episodes of intensified insulin treatment to induce maximal beta-cell rest, and dietician support to promote dietary habits that minimize the likelihood of bacterial reflux from the duodenum to the pancreatic duct, will lead to preservation of beta cell function.
This trial will examine whether the AIDIT protocol initiated within one week from diagnosis could preserve insulin production in children with Type 1 Diabetes.
Detailed description
The study is a 2-arm, randomized, open, single center, clinical trial. Eligible patients with type 1 diabetes will be randomized to the AIDIT protocol or treatment as usual (TAU).
All patients diagnosed with T1D and included in the study will receive standard of care. In addition, the AIDIT protocol will include 1) treatment with Azithromycin for 52 weeks using a protocol for children with cystic fibrosis, 2) repeated treatments with intensified supervised high dose insulin infusion, and 3) extra advice and support from the study dietician.
- Azithromycin Azithromycin will be administered orally. Azithromycin will be given three times per week for 52 weeks. The dose will be 500 mg for children with body weight ≥ 30 kg and 250 mg if body weight < 30 kg.
- Intensified supervised high dose insulin infusions Participants will, in addition to Azithromycin, also be subjected to intensified anti-diabetic treatment to achieve increased beta-cell rest. This will be achieved by insulin lispro given as a supervised iv infusion for 72 hours within one week of diagnosis and by subcutaneous infusion 6-8 hours during one day in study week 5, 9, 13, 17 (±1 week) and 25, 34, 43 (±2 weeks) after inclusion. The intensified treatments will aim to target a blood glucose level of 4.0 ± 0.5 mmol/l. The efficacy of the intended maximal beta cell rest will be evaluated by measurement of plasma glucose and endogenous C-peptide. If C-peptide remains positive during the supervised infusion of insulin lispro this will be interpreted as that the insulin dose needs to be increased at the next treatment occasion to achieve beta-cell rest.
- Dietician support Participants will receive extra advice and support from the study dietician within the first week after randomization, and after 7 and 17 weeks. Personalized nutritional advice on intake of carbohydrates, fat and protein based on four-day food records will be given to in order to reduce insulin resistance and insulin need in accordance with ISPAD guidelines. By giving nutritional advices on less volume of the meals, especially of the fluid (maximum 300 ml per meal), and by trying to extend the meal time to at least 20 minutes, the reflux into ductus pancreaticus might be reduced.
All patients will be offered an examination of their pancreas with MRI at 0 and 12 months after inclusion. In addition, plasma samples taken at inclusion and after 1.5 and 12 months will be analysed for the presence of cell-free DNA indicating ongoing cell destruction. Cell-specific methylation patterns of this cell-free DNA will be analysed to determine cell-type specific cell death.
The effect of the addition of treatment according to the AIDIT protocol will be evaluated with a Mixed Meal Tolerance Test (MMTT) to explore the effect on preservation of beta-cell function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a 2-arm, randomized, open, clinical trial comparing the AIDIT protocol with treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| AIDIT protocol | Experimental | Drug: Azithromycin Monohydrate, Drug: Insulin Lispro, Behavioral: Dietician supportTreatment as usual with the addition of: i) Azithromycin Monohydrate, three times a week (≥ 48 h between doses) during 52 weeks. 500 mg if body weight ≥ 30 kg, 250 mg if body weight < 30 kg. ii) Extra intensive insulin treatment periods for maximum beta-cell rest with Insulin lispro (Sanofi). This treatment will be given i.v. for one episode of 72 hours in the first week after inclusion and s.c. on seven 6-8 h occasions during the study year. The dose will be individually titrated to reach target blood glucose 4.0±0.5 mmol/L. ii) Dietician support; Extra advice and support from the study dietician within the first week after randomization and after 1.5 and 4 months. |
| Control | No intervention | –Patients will receive treatment as usual (TAU). All patients will receive standard therapeutic treatment consisting of insulin replacement with insulin analogues aiming for normoglycemia from diagnosis. Rapid acting insulin analogue will be administered via insulin pump (continuous subcutaneous infusion) with access to insulin injections in case of malfunction in the pump system. |
Who may qualify
- Ages
- 72 to 192 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinically diagnosed Type 1 Diabetes. First injection of insulin maximum ten days prior to inclusion.
- Must be willing and capable of taking the study drugs, perform tests and follow up as described as judged by the investigator.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up.
- Aged 6.00 -15.99 years at inclusion.
- Females of childbearing potential must agree to avoid pregnancy during the study period (by abstinence from heterosexual intercourse, or by hormonal or barrier contraception) and have a negative urine pregnancy test.
Key exclusion criteria (17 listed)
- Other diabetes diagnosis than Type 1 diabetes as judged by the investigator
- Severe ketoacidosis (DKA) with lowest pH <7.1 within 36 hours from diagnosis.
- Treatment with any oral or injected anti-diabetic medications other than insulin
- Significantly abnormal haematology results at screening.
- Participation in other clinical trials with a new chemical entity within the previous 3 months.
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 |
|---|---|---|
| Azithromycin MonohydrateAlso: Azithromycin Sandoz, AzithromaxAzithromycin Monohydrate tablet (Azithromycin Sandoz) or oral suspension (Azithromax). | Drug | AIDIT protocol |
| Insulin LisproAlso: Insulin lispro SanofiSolution for intravenous or subcutaneous use | Drug | AIDIT protocol |
| Dietician supportDietary advice | Behavioural | AIDIT protocol |
Primary outcome
Stimulated C-peptide during an MMTT
Time frame: 12 months after inclusion
Residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide two-hour under the curve profile measured one year after study inclusion.
21 secondary outcomes
>60% of time in target blood glucose levels
Time frame: two weeks in the 12th month after initiation of the study treatment
Time in target blood glucose levels
Time frame: 30 days in the 12th month after initiation of the study treatment
Time in range blood glucose levels
Time frame: 30 days in the 12th month after initiation of the study treatment
Insulin dose
Time frame: 30 days in the 12th month after initiation of the study treatment
HbA1c levels
Time frame: 12 months
Hypoglycaemic events
Time frame: From study start to 12 months
Time in hypoglycemic range
Time frame: 30 days in the 12th month
IDAA1c
Time frame: 12 months
Pro-insulin/c-peptide
Time frame: 12 months
Pancreas inflammation
Time frame: 12 months
QoL
Time frame: 12 months
Gastrointestinal symptoms
Time frame: 12 months
Time spent eating
Time frame: 12 months
Intake of saturated fat
Time frame: four days in the 12th month
Intake of fruit
Time frame: four days in the 12th month
Intake of macronutrients
Time frame: four days in the 12th month
Intake of fibre
Time frame: four days in the 12th month
Physical activity measured with accelerometer
Time frame: 6 months
Physical activity measured with accelerometer
Time frame: 12 months
Oral microbiome
Time frame: 12 months
Change in stimulated C-peptide
Time frame: change from 6 weeks to 12 months after initiation of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- 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.
Gun Forsander, MD, PhD principal investigator
The Queen Silvia Children's Hospital /Sahlgrenska University Hospital (SU), Sahlgrenska Academy, Dept of Pediatrics, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin Monohydrate, Insulin Lispro and Dietician support in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 17 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 24 Sep 2018. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olle Korsgren, MD, PhD (+46176114187, olle.korsgren@igp.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulated C-peptide during an MMTT (time frame: 12 months after inclusion). 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 24 Sep 2018.