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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674332
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
maii medhat nawara, Ain Shams University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2019
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : December 14, 2020

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. time needed to achieve glycemic control [ Time Frame: 1 year ]
    glycemic control assessed by fasting and postprandial blood sugar


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   they should be pregnant females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women with gestational diabetes mellitus
  • between 24-28 weeks gestation

Exclusion Criteria:

  • other endocrinological abnormalities
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674332


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
More Information
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Responsible Party: maii medhat nawara, associate professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04674332    
Other Study ID Numbers: 323/2019
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs