NCT04674332

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

December 14, 2020

Last Update Submit

September 4, 2021

Conditions

Long Acting Insulin in Control of Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • time needed to achieve glycemic control

    glycemic control assessed by fasting and postprandial blood sugar

    1 year

Study Arms (2)

long acting insulin

EXPERIMENTAL
Drug: Long acting insulin

multiple dose regimen

ACTIVE COMPARATOR
Drug: multiple dose regimen

Interventions

Long acting insulinDRUG

long acting insulin analogue once daily at bed time

long acting insulin
multiple dose regimenDRUG

intermediate and short acting insulin

multiple dose regimen

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthey should be pregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • other endocrinological abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Insulin, Long-Acting

Intervention Hierarchy (Ancestors)

InsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

September 1, 2019

Primary Completion

December 14, 2020

Study Completion

December 14, 2020

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

EG(1)