Long Acting Insulin Versus Multiple Dose Regimen for Cont... | NCT04674332

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

NCT04674332

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Sep 8, 2021Actual

Enrollment

148Actual

Phase

Phase 2Phase 3

Conditions

Long Acting Insulin in Control of Gestational Diabetes Mellitus

Interventions

Long acting insulin
multiple dose regimen

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Dec 14, 2020Actual

Completion Date

Dec 14, 2020Actual

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 14, 2020

First Posted Date

Dec 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2021

Last Update Posted Date

Sep 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
long acting insulin	Experimental		Drug: Long acting insulin
multiple dose regimen	Active Comparator		Drug: multiple dose regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Long acting insulin	Drug	long acting insulin analogue once daily at bed time	long acting insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time needed to achieve glycemic control	glycemic control assessed by fasting and postprandial blood sugar	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

other endocrinological abnormalities

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

they should be pregnant females

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D049528	Insulin, Long-Acting

Ancestor Terms

ID	Term
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided