Type 1 Diabetes Mellitus With HypoglycemiaPhase 4NCT04664764
Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.
A Phase 4 study testing Degludec, Glargine and NPH insulin in people with Type 1 Diabetes Mellitus With Hypoglycemia and type1diabetes, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hypoglycemia, type1diabetes
- What is being tested?
- Degludec, Glargine and NPH insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2019to 10 Mar 2021
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Toddlers and preschool children with T1D on insulin therapy
Who cannot join
- patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (MODY) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11375
Safinaz ElHabashi, 01116603336, safinazelhabashy@med.asu.edu.eg
About this study
Official title: The Effect of Long- and Intermediate-acting Insulins on Glycemic Control and Risk of Hypoglycemia Among Toddlers and Preschool Children With Newly Onset Type 1 Diabetes Mellitus: A Randomized Three Armed Trial
Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.
- Being tested
- Degludec, Glargine, NPH insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegludecDrug
Basal insulin comparison
GlargineDrug
Basal insulin comparison
NPH insulinDrug
Basal insulin comparison
| Study group | Role | What they receive |
|---|---|---|
| degludec arm | Active comparator | Group A received insulin degludec, Receives: Drug: Degludec |
| glargine arm | Active comparator | group B received insulin glargine Receives: Drug: Glargine |
| NPH group | Active comparator | Group C received NPH insulin Receives: Drug: NPH insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the effectiveness of insulin degludec to insulin glargine and NPH
to compare the effectiveness of insulin degludec in the form of HBA1C and frequency of hypoglycemia to insulin glargine and NPH in toddlers and preschool children with T1D in terms of HbA1C, IDD and frequency of hypoglycemic episodes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start21 Feb 2019
- Primary completion28 Feb 2021 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
- Investigators
- Safinaz El Habashy, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664764
- Sponsor's protocol ID
- Basal insulin toddlers
- Status last verified
- Feb 2021
- First submitted
- 1 Dec 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long- and Intermediate-acting Insulins on Glycemic Control and Risk of Hypoglycemia Among Toddlers and Preschool Children With Newly Onset Type 1 Diabetes Mellitus: A Randomized Three Armed Trial
- ClinicalTrials.gov ID
- NCT04664764
- Acronym / sponsor ID
- Basal insulin toddlers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 11 Dec 2020 (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.
Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| degludec arm | Active comparator | Drug: DegludecGroup A received insulin degludec, |
| glargine arm | Active comparator | Drug: Glarginegroup B received insulin glargine |
| NPH group | Active comparator | Drug: NPH insulinGroup C received NPH insulin |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Toddlers and preschool children with T1D on insulin therapy
Key exclusion criteria (1 listed)
- patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (MODY) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening.
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 |
|---|---|---|
| DegludecBasal insulin comparison | Drug | degludec arm |
| GlargineBasal insulin comparison | Drug | glargine arm |
| NPH insulinBasal insulin comparison | Drug | NPH group |
Primary outcome
to compare the effectiveness of insulin degludec to insulin glargine and NPH
Time frame: 6 months
to compare the effectiveness of insulin degludec in the form of HBA1C and frequency of hypoglycemia to insulin glargine and NPH in toddlers and preschool children with T1D in terms of HbA1C, IDD and frequency of hypoglycemic episodes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No. Data will be available upon request
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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.
Safinaz El Habashy principal investigator
Ain Shams University
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 Degludec, Glargine and NPH insulin in people with Type 1 Diabetes Mellitus With Hypoglycemia and type1diabetes, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eman sakr (+20206603336, niron85@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the effectiveness of insulin degludec to insulin glargine and NPH (time frame: 6 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 16 Feb 2021.