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Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Primary Purpose

Type 1 Diabetes Mellitus With Hypoglycemia, type1diabetes

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Degludec
Glargine
NPH insulin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus With Hypoglycemia

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Toddlers and preschool children with T1D on insulin therapy

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

degludec arm

glargine arm

NPH group

Arm Description

Group A received insulin degludec,

group B received insulin glargine

Group C received NPH insulin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2020
Last Updated
February 12, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04664764
Brief Title
Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Hypoglycemia, type1diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
degludec arm
Arm Type
Active Comparator
Arm Description
Group A received insulin degludec,
Arm Title
glargine arm
Arm Type
Active Comparator
Arm Description
group B received insulin glargine
Arm Title
NPH group
Arm Type
Active Comparator
Arm Description
Group C received NPH insulin
Intervention Type
Drug
Intervention Name(s)
Degludec
Intervention Description
Basal insulin comparison
Intervention Type
Drug
Intervention Name(s)
Glargine
Intervention Description
Basal insulin comparison
Intervention Type
Drug
Intervention Name(s)
NPH insulin
Intervention Description
Basal insulin comparison
Primary Outcome Measure Information:
Title
to compare the effectiveness of insulin degludec to insulin glargine and NPH
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Toddlers and preschool children with T1D on insulin therapy Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eman sakr
Phone
+20206603336
Email
niron85@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safinaz El Habashy
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11375
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safinaz ElHabashi
Phone
01116603336
Email
safinazelhabashy@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon request

Learn more about this trial

Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

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