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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

NCT03106870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-06-14

Study results available
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Summary

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

DRUG

Insulin Mixtard

Insulin dose: * 0.7 IU/Kg (at the second trimester of pregnancy). * 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

DRUG

Metformin

Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT03106870 on ClinicalTrials.gov