Type 1 DiabetesPhase 4SHINENCT03312478
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
A Phase 4 study testing Blood draw for insulin auto-anti body tests* in people with Type 1 Diabetes, run by Sanofi at 1 site in Pakistan.
Trial summary
Primary Objective: To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics. Secondary Objectives: To document the profile of Type 1 diabetes patients. Read more about this study
- Who is it for?
- Ages 2 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Blood draw for insulin auto-anti body tests*
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Oct 2017to 19 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 2 years and ≤ 20 years.
- Type 1 diabetes mellitus (T1DM) at any stage of life assessed as:
- Insulin initiated within one year of diagnosis.
- One or more islet autoantibodies (insulin auto-antibodies [IAA], glutamic acid decarboxylase (GAD), or IA2) positive at the time of enrolment. The laboratory value for IAA ≥ 2.4 units/mL, ≥ 10 IU/mL for IA2 and ≥ 5 IU/mL for anti-GAD to be labelled as positive.
- Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age.
- Age ≥ 2 years and ≤ 20 years. Every control will be matched for a specific patient within ± two years of age.
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- Non diabetic.
- All islet autoantibodies negative at the time of enrolment (IAA, GAD, or IA2). The laboratory value for IAA ≤ 2.4 units/mL, ≤ 10 IU/mL for IA2, and ≤ 5 IU/mL for anti-GAD to be labelled as negative.
- Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than 18 years of age.
Who cannot join
- Age ≤ 2 years and >20 years.
- Patients with any other pre-existing auto-immune disease.
- Gestational Diabetes.
- Pregnant Woman.
- Age ≤ 2 years and > 20 years.
- Patient with history of Type 1 (T1) and Type 2 Diabetes Mellitus (T2DM).
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- History of T1 and T2DM in siblings.
- Gestational Diabetes.
- Pregnant Woman.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
Primary Objective:
To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics.
Secondary Objectives:
- To document the profile of Type 1 diabetes patients.
- To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes.
- To capture the current therapeutic management.
Read the detailed description
The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days.
*Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients.
Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.
- Conditions
- Type 1 Diabetes
- Being tested
- Blood draw for insulin auto-anti body tests*
- 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.
Blood draw for insulin auto-anti body tests*Drug
Pharmaceutical form: N/A
Route of administration: N/A
| Study group | Role | What they receive |
|---|---|---|
| Case | Other | Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases Receives: Drug: Blood draw for insulin auto-anti body tests* |
| Control | Other | Age-matched non-diabetic controls as described in the inclusion criteria for controls Receives: Drug: Blood draw for insulin auto-anti body tests* |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds of Type 1 Diabetes Mellitus child having a diabetic parent
Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables
Measured: 12 months
Secondary outcomes (13)
Characterization of this population by gender
Categorical variables (gender) will be presented as proportions
Measured: 12 months
Characterization of this population by age
Categorical variables (age) will be presented as proportions
Measured: 12 months
Characterization of this population by socio-economic profile
Categorical variables (socio-economic profile) will be presented as proportions
Measured: 12 months
Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
Mean HbA1c
Measured: 12 months
Standard deviation of HbA1c in T1DM patients
Standard deviation of HbA1c
Measured: 12 months
Distribution of prescribed therapies by type of insulin to T1DM patients
Distribution of prescribed therapies by type of insulin will be presented as proportions
Measured: 12 months
Means of fasting blood glucose (FBG) in T1DM patients
Mean Fasting Blood Glucose
Measured: 12 months
Standard deviation of FBG in T1DM patients
Standard deviation of FBG
Measured: 12 months
Duration of diabetes in parent
Mean duration of diabetes in parent
Measured: 12 months
Mean duration of diabetes in parent
Standard deviation of duration of diabetes in parent
Measured: 12 months
Characterization of family history of diabetes
Categorical variables will be measured as proportions
Measured: 12 months
Characterization of frequency of consultation
Number of consultations per month
Measured: 12 months
Characterization of diabetes education
Number of sessions per month
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start13 Oct 2017
- Primary completion19 Aug 2018
- Study completion19 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312478
- Sponsor's protocol ID
- LANTUL08473
- Other IDs
- U1111-1200-1995
- Acronym
- SHINE
- Status last verified
- Apr 2022
- First submitted
- 29 Sep 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
- ClinicalTrials.gov ID
- NCT03312478
- Acronym / sponsor ID
- SHINE / LANTUL08473
- Conditions
- Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 19 Aug 2018 (actual)
- First posted
- 17 Oct 2017 (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.
Primary Objective:
To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics.
Secondary Objectives:
- To document the profile of Type 1 diabetes patients.
- To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes.
- To capture the current therapeutic management.
Detailed description
The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days.
*Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients.
Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Other | Drug: Blood draw for insulin auto-anti body tests*Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases |
| Control | Other | Drug: Blood draw for insulin auto-anti body tests*Age-matched non-diabetic controls as described in the inclusion criteria for controls |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age ≥ 2 years and ≤ 20 years.
- Type 1 diabetes mellitus (T1DM) at any stage of life assessed as:
- Insulin initiated within one year of diagnosis.
- One or more islet autoantibodies (insulin auto-antibodies [IAA], glutamic acid decarboxylase (GAD), or IA2) positive at the time of enrolment. The laboratory value for IAA ≥ 2.4 units/mL, ≥ 10 IU/mL for IA2 and ≥ 5 IU/mL for anti-GAD to be labelled as positive.
- Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age.
Key exclusion criteria (10 listed)
- Age ≤ 2 years and >20 years.
- Patients with any other pre-existing auto-immune disease.
- Gestational Diabetes.
- Pregnant Woman.
- Age ≤ 2 years and > 20 years.
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 |
|---|---|---|
| Blood draw for insulin auto-anti body tests*Pharmaceutical form: N/A Route of administration: N/A | Drug | Case, Control |
Primary outcome
Odds of Type 1 Diabetes Mellitus child having a diabetic parent
Time frame: 12 months
Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables
13 secondary outcomes
Characterization of this population by gender
Time frame: 12 months
Characterization of this population by age
Time frame: 12 months
Characterization of this population by socio-economic profile
Time frame: 12 months
Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
Time frame: 12 months
Standard deviation of HbA1c in T1DM patients
Time frame: 12 months
Distribution of prescribed therapies by type of insulin to T1DM patients
Time frame: 12 months
Means of fasting blood glucose (FBG) in T1DM patients
Time frame: 12 months
Standard deviation of FBG in T1DM patients
Time frame: 12 months
Duration of diabetes in parent
Time frame: 12 months
Mean duration of diabetes in parent
Time frame: 12 months
Characterization of family history of diabetes
Time frame: 12 months
Characterization of frequency of consultation
Time frame: 12 months
Characterization of diabetes education
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood draw for insulin auto-anti body tests* in people with Type 1 Diabetes, run by Sanofi at 1 site in Pakistan.
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 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. 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 Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds of Type 1 Diabetes Mellitus child having a diabetic parent (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 25 Apr 2022.