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Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.

NCT03928340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-05-28

No results posted yet for this study

Summary

A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DRUG

Metformin

40 patients will be treated with metformin (1 gm twice daily (with the 2 main meals)), combined with insulin therapy

DRUG

Insulin

40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)

Sponsors & Collaborators

  • Amal Kotb Abdallah

    collaborator UNKNOWN

  • Amir Gabr

    collaborator UNKNOWN

  • Mohamed Abdeltawwab Mahmoud

    collaborator UNKNOWN

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Amal kotb · Beniswef university hospital

  • Amir Gabr · Cairo university kasrelainy hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2020-03-29
Completion
2020-03-29

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928340 on ClinicalTrials.gov