NCT04674332
Completed
Phase 2
Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- time needed to achieve glycemic control
Overview
Brief Summary
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pregnant women with gestational diabetes mellitus
- •between 24-28 weeks gestation
Exclusion Criteria
- •other endocrinological abnormalities
Arms & Interventions
long acting insulin
Experimental
Intervention: Long acting insulin (Drug)
multiple dose regimen
Active Comparator
Intervention: multiple dose regimen (Drug)
Outcomes
Primary Outcomes
time needed to achieve glycemic control
Time Frame: 1 year
glycemic control assessed by fasting and postprandial blood sugar
Secondary Outcomes
No secondary outcomes reported
Investigators
maii medhat nawara
associate professor
Ain Shams University
Study Sites (1)
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