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

NCT ID: NCT04674332

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-14

Brief Summary

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

Detailed Description

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Conditions

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Long Acting Insulin in Control of Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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long acting insulin

Group Type EXPERIMENTAL

Long acting insulin

Intervention Type DRUG

long acting insulin analogue once daily at bed time

multiple dose regimen

Group Type ACTIVE_COMPARATOR

multiple dose regimen

Intervention Type DRUG

intermediate and short acting insulin

Interventions

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Long acting insulin

long acting insulin analogue once daily at bed time

Intervention Type DRUG

multiple dose regimen

intermediate and short acting insulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* other endocrinological abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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maii medhat nawara

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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323/2019

Identifier Type: -

Identifier Source: org_study_id

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