Other Clinical Trial - Long Acting Insulin Versus Multiple NCT04674332

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin

Recruitment information / eligibility
Status	Completed
Enrollment	148
Est. completion date	December 14, 2020
Est. primary completion date	December 14, 2020
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years to 45 Years
Eligibility	Inclusion Criteria: - pregnant women with gestational diabetes mellitus - between 24-28 weeks gestation Exclusion Criteria: - other endocrinological abnormalities

Drug:
• Long acting insulin
long acting insulin analogue once daily at bed time
• multiple dose regimen
intermediate and short acting insulin

Locations
Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors *(1)*
Lead Sponsor	Collaborator
Ain Shams University

Egypt,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	time needed to achieve glycemic control	glycemic control assessed by fasting and postprandial blood sugar	1 year