Back to resultsLong Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
Primary Purpose
Long Acting Insulin in Control of Gestational Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Long acting insulin
multiple dose regimen
Sponsored by
About this trial
This is an interventional treatment trial for Long Acting Insulin in Control of Gestational Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- pregnant women with gestational diabetes mellitus
- between 24-28 weeks gestation
Exclusion Criteria:
- other endocrinological abnormalities
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
long acting insulin
multiple dose regimen
Arm Description
Outcomes
Primary Outcome Measures
time needed to achieve glycemic control
glycemic control assessed by fasting and postprandial blood sugar
Secondary Outcome Measures
Full Information
NCT ID
NCT04674332
First Posted
December 14, 2020
Last Updated
September 4, 2021
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04674332
Brief Title
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
Official Title
Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Acting Insulin in Control of Gestational Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
long acting insulin
Arm Type
Experimental
Arm Title
multiple dose regimen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Long acting insulin
Intervention Description
long acting insulin analogue once daily at bed time
Intervention Type
Drug
Intervention Name(s)
multiple dose regimen
Intervention Description
intermediate and short acting insulin
Primary Outcome Measure Information:
Title
time needed to achieve glycemic control
Description
glycemic control assessed by fasting and postprandial blood sugar
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
they should be pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women with gestational diabetes mellitus
between 24-28 weeks gestation
Exclusion Criteria:
other endocrinological abnormalities
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
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