Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04674332
• Collaborator: (none)
• Enrollment: 148
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.4
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Long Acting Insulin in Control of Gestational Diabetes Mellitus	Drug: Long acting insulin; Drug: multiple dose regimen	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Dec 14, 2020
• Actual Study Completion Date: Dec 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: long acting insulin	Drug: Long acting insulin; long acting insulin analogue once daily at bed time
Active Comparator: multiple dose regimen	Drug: multiple dose regimen; intermediate and short acting insulin

Outcome Measures

Primary Outcome Measures

1. time needed to achieve glycemic control [1 year]

   glycemic control assessed by fasting and postprandial blood sugar

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• pregnant women with gestational diabetes mellitus

• between 24-28 weeks gestation

Exclusion Criteria:

• other endocrinological abnormalities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: maii medhat nawara, associate professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04674332
• Other Study ID Numbers: 323/2019
• First Posted: Dec 19, 2020
• Last Update Posted: Sep 8, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Insulin, Long-Acting

Study Results

No Results Posted as of Sep 8, 2021